Miscellaneous devices · 21 CFR 872 Subpart G
Porcelain Powder
FDA device type “Powder, Porcelain”.
- Companies listing it
- 13294 makers
- Brands and models
- 5,824
- 510(k) clearances
- 49192 in five years
- FDA name
- Powder, Porcelain
510(k) clearances per year, 1976–2026
Companies that list EIH
132 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | IPS Empress CAD · n!ce Crown · n!ce Inlay · n!ce Onlay · +7 | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | ATLANTIS Crown · Celtra Ceram · CELTRA Duo · Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit · +25 | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | BruxZir Basic Shade Coloring Liquid A1 · BruxZir Basic Shade Coloring Liquid A2 · BruxZir Basic Shade Coloring Liquid A3 · BruxZir Basic Shade Coloring Liquid A3.5 · +1,465 | 56 | 2026 |
| ARUM DENTISTRY Co., Ltd | South Korea | Maker | Arena · Arena Star · Galaxy Star · Montblanc · +3 | 17 | 2025 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Zircos | 15 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Aidite · Biomic Color Opaque · Dental Crystallized Ceramics (HT,LT,ST) · Dental Zirconia Ceramic · +7 | 16 | 2026 |
| Rizhao HuGe Biomaterials Company, Ltd. | China | Maker | HF-Etchant Hydrofluoric Acid Etching Gel | 13 | 2025 |
| Osstem Implant Co., Ltd. | South Korea | Maker | Estar-Z · Estar-Z HT · Estar-Z Multi · Estar-Z ST · +2 | 68 | 2026 |
| Shofu Inc | Japan | Maker | DENTADISC ZR · LAYZIR DISC · PORCELAIN STAIN POWDER · VINTAGE AL · +16 | 96 | 2025 |
| GC America Inc. | United States | Maker | Aadva Zr Coloring Liquid · Creation · Creation CC · CREATION CP-ZI PORCELAIN · +35 | 137 | 2026 |
| Hiossen Inc. | United States | Maker | Smartfit Final Hybrid Denture | 26 | 2026 |
| Ultradent Products, Inc. | United States | Maker | EtchArrest · Porcelain Etch · Ultradent Porcelain Repair Kit | 95 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | AMT0010A05 · AMT0010A1 · AMT0010A2 · AMT0010A3 · +3,471 | 23 | 2025 |
| Ivoclar Vivadent, AG | United States | Maker | CAD/CAM CEREC Starter Kit · IPS Build-Up Liquid · IPS Classic · IPS Classic Powder Opaquer · +49 | 94 | 2026 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | CERABIEN · CERABIEN MiLai · CERABIEN ZR · CERABIEN ZR SS BASIC FULL KIT · +34 | 32 | 2025 |
| Chengdu Besmile Medical Technology Co., Ltd. | China | Maker | Dental Glass Ceramics · Dental Porcelain Powder · Pre-Sintered Zirconia Coloring Liquid · Zirconia Dental Ceramics | 5 | 2026 |
| Liaoning Upcera Co., Ltd | China | Maker | Ceramic Etchant (HF-5 and HF-9) · Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) · DUO,Aevra · Glaze Paste, Glaze Powder, and Glaze Liquid · +3 | 10 | 2026 |
| Dental Direkt GmbH | Germany | Maker | DD Art Elements · DD Basic Shade · DD Bio ZW iso · DD Bio ZX² · +11 | 9 | 2024 |
| Shandong Huge Dental Material Corporation | China | Maker | Eternal Art Porcelain Powders · Eternal Art Stain&Glaze Porcelain Powders · NOBILCAM Zirconia Disc · Zirconia Block | 8 | 2026 |
| Imagine Milling Technologies, LLC | United States | Maker | Arena Star, Montblanc · DD Bio ZX² · DD cubeX² ML · Non-Sterile Zirconia Block (Model: Arena Monoblanc, Trione C, Trione HT+) | 4 | 2026 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | China | Maker | Dental Glass Ceramics · Dental Lithium Disilicate Glass-Ceramics · Dental Zirconia Pre-shaded Block · GUSROM · +2 | 3 | 2023 |
| Whitepeaks Dental Solutions GmbH | Germany | Maker | Copran Color · Copran Zr | 3 | 2024 |
| Shenzhen Xiangtong Co., Ltd. | China | Maker | Coloring Liquid · Glass Ceramic · X-cera Pre-shaded Zirconia Blanks · X-Cera Zirconia Blanks · +2 | 3 | 2025 |
| Yilink (Tianjin) Biotechnology Co., Ltd. | China | Maker | Dental Glass-Ceramic Block · Dental porcelain powder · Dental Zirconia Ceramic Block · Glass Ceramics · +1 | 3 | 2024 |
| Bisco, Inc. | United States | Maker | BARRIER GEL · PORCELAIN ETCHANT 4% · PORCELAIN ETCHANT 9.5% | 88 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | — | 20 | 2026 |
| Zirkonzahn Srl | Italy | Maker | Aquarell · Color Liquids · ICE Prettau · ICE Transluzent Plus · +2 | 10 | 2023 |
| Den-Mat Holdings, LLC | United States | Maker | DenMat Multilayered Zirconia Disc | 8 | 2026 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Maker | Celay Blanks Celay Optimizer · Hi-Ceram · In-Ceram AL Cube · In-Ceram Alumina · +22 | 8 | 2026 |
| Hass Corp. | South Korea | Maker | Amber LiSi-POM Series · Amber LiSi-POZ Series · Amber Mill Meso · Amber Mill Q Series & Amber Mill Direct Series · +5 | 6 | 2026 |
| DENTALMAX Co., Ltd | South Korea | Maker | LUXEN 5G · LUXEN CL Dental Liquid · LUXEN Smile · LUXEN Zr | 3 | 2024 |
| Keystone Industries | United States | Maker | Enamelite Ceramic Spray Glaze | 2 | 2025 |
| Hunan Vsmile Biotechnology Co.,Ltd | China | Maker | Dental Glass Ceramics Blocks (HT, LT, MT) · Dithilicate Glass Block · Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2 | 2024 |
| Bloomden Bioceramics (HuNan) Co.,Ltd. | China | Maker | Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3D-Pro-ML, UT, UT-C, UT-ML, HTP-plus · Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3DP-Pro-ML, UTP, UTP-C, UTP-ML · Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: STP,STP-C,STP-ML,SHTP,SHTP-C,SHTP-ML · Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD:HT-plus,ST,ST-C,ST-ML,SHT,SHT-C,SHT-ML · +2 | 2 | 2026 |
| Hunan Qinghao Puzhong Technology Co., Ltd. | China | Maker | Dental Zirconia Blank | 2 | 2026 |
| The Argen Corporation | United States | Maker | ArgenZ Anterior · ArgenZ Color Modifier · ArgenZ Esthetic · ArgenZ Esthetic Plus · +24 | 11 | 2024 |
| Amann Girrbach AG | Austria | Maker | Ceramill HT+ PS · Ceramill HT+ white · Ceramill Liquid · Ceramill Liquid fx · +9 | 3 | 2026 |
| DMAX Co., Ltd. | South Korea | Maker | ADD-Z · Alpha+ · CAMeleon Coloring Liquid · Chang's Liquid · +15 | 2 | 2025 |
| Hunan Hualian Special Ceramics Co., Ltd | China | Maker | Dental Zirconia Block · Dental Zirconia Block (Models HT, ST, SHT, UT, 3D-Pro,4D-Max) · HT A1 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30) · HT A2 D98/D95/92*75 (Thickness: 10,12,14,16,18,20,22,25,30) · +184 | 1 | 2024 |
| Vatech mcis Co., Ltd. | South Korea | Maker | Chairside Zirconia · Perfit CL · Perfit FS · Perfit FS Dental Zirconia Fully Sintered Block · +3 | 1 | 2023 |
| Creamed GmbH & Co. Produktions- und Handels KG | Germany | Maker | AMBARINO · ENA CAD | 1 | 2022 |
| DENKEN-HIGHDENTAL Co., Ltd. | Japan | Maker | KDF Zirconia Disc | 1 | 2022 |
| estetic ceram ag | Liechtenstein | Maker | iNK3D · mµILLUSION · priti perfect | 1 | 2025 |
| Hangzhou Thales Medtech Co., Ltd. | China | Maker | Additive Manufacturing Zirconia Customized Restoration | 1 | 2024 |
| Zirdent New Material Co.,Ltd | China | Maker | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · Zirconia Blocks · Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 1 | 2021 |
| Changsha Honchon Technology Co., LTD | China | Maker | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 1 | 2022 |
| Hunan Ceramaster Material Technology Co., Ltd. | China | Maker | Dental Zirconia Blank | 1 | 2024 |
| Topzir Biotech Co., Ltd | China | Maker | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · 4D Ultra Fit Multilayer, 3D Pro Ultra Multilayer | 1 | 2023 |
| Anhui Miisen Intelligence Technology Co., Ltd. | China | Maker | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | 1 | 2024 |
| Dental Creativ Management GmbH | Germany | Maker | DCMhotbond zircon | 1 | 2026 |
| Doctus Global | South Korea | Maker | Easy On Universal Glaze & Stain | 1 | 2023 |
| Fuzhou Rick Brown Biomaterials Co. Ltd. | China | Maker | Dental Lithium Disilicate Glass-Ceramic | 1 | 2023 |
| Hangzhou IVISTA Medical Devices Co., Ltd | China | Maker | Zirconia Block | 1 | 2024 |
| Liaoning Rachcera Material Technology Co.,Ltd. | China | Maker | Dental Lithium Disilicate Glass Ceramic,HT, ML-HT, LT, ML-LT, MT, MO, HO | 1 | 2024 |
| Zhejiang Zahndent Biotechnology Co.,Ltd | China | Maker | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 1 | 2024 |
| Reliance Orthodontic Products, Inc. | United States | Maker | — | 32 | 2021 |
| Jensen Industries, Inc. | United States | Maker | Imagine Enamel Liquid · InSync Ceramic System · Lava Esthetic · LAVA Frame · +4 | 17 | 2019 |
| Talladium, Inc. | United States | Maker | Luminesse Anterior Zirconia AT · Luminesse Multilayer Anterior Zirconia AT · Luminesse One For All ZR · Luminesse One for All ZR ML · +5 | 7 | 2016 |
| Davis Schottlander & Davis, Ltd. | United Kingdom | Maker | — | 7 | 2004 |
| United Dental Resources Corporation | United States | Maker | GenesisZr 4Y Zirconia · GenesisZr 4Y+ (ST1100) Zirconi · GenesisZr UHT700 Zirconia | 3 | 2021 |
| Cendres+Metaux SA | Switzerland | Maker | Livento® press · Soprano® · Soprano® 10 · Soprano® Surface | 2 | 2020 |
| Sagemax Bioceramics, Inc. | United States | Maker | NexxZr + Coloring Liquids · NexxZr + Multi · NexxZr + Multi 2 · NexxZr Effect Coloring Liquids · +8 | 2 | 2014 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | China | Maker | dental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A1,layer:Multi,Single · dental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A2,layer:Multi,Single · dental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A3,layer:Multi,Single · dental zirconia 3d-pro, size:98x10, 98x12, 98x14, 98x16, 98x18,98x20,98x22,98x25,98x30, shade:W,A3.5,layer:Multi,Single · +62 | 1 | 2020 |
| pritidenta GmbH | Germany | Maker | GC Initial Zirconia Disk Multilayer Elite · priti®crown · priti®multidisc ZrO2 Multi Tranlsucent PLUS · pritimultibloc ZrO2 Extra Translucent · +15 | 1 | 2017 |
| U&C International Co., Ltd. | South Korea | Maker | BlueTooth · Chang's DA-vich · Chang's Iris · Everest · +5 | 1 | 2019 |
| YETI Dentalprodukte GmbH | Germany | Maker | — | 1 | 2018 |
| Baot Biological Technology Co., Ltd. | China | Maker | Dental Ceramic · Dental Porcelain · Formative Liquid | 1 | 2019 |
| De Corematrix Co.Ltd. | China | Maker | Dental Zirconia Blocks · VENUS · ZECHUAN | 1 | 2020 |
| Kerox Kft. | Hungary | Maker | Kerox Dental Zircostar · Kerox Dental Zircostar Zirconia Blank | 1 | 2012 |
| Qinhuangdao Silide Ceramic Technology Co., Ltd. | China | Maker | Ceramic Denture Zirconia Ceramics Block | 1 | 2018 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Carmen · Carmen CCS Compact Ceramic System · ceraMotion · ceraMotion LiSi · +3 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Digital Age Dental Laboratories, Ltd. | United States | Maker | Straumann Variobase Abutments | — | — |
| IDOC Dental Lab | United States | Maker | ADD-Z; Alpha+; MaxZir; Natura M; Natura S; NaturaZ HT; NaturaZ Illusion; NaturaZ Series (B16, B20, B42, B60, B98, B100) · Chairside Zirconia; Perfit FS Dental Zirconia Fully Sintered Block; RAYZir FS · Chairside Zirconia; Perfit FS; RAYZir FS · Perfit CL · +2 | — | — |
| Shenzhen UP3D Tech Co., Ltd. | China | Maker | POWDER, PORCELAIN-Dental Glass Ceramic · POWDER, PORCELAIN-Dental Zirconia Blocks | — | — |
| Amsusa | United States | Maker | ECLIPSE · ECLIPSE 1 · ECLIPSE 2 · ECLIPSE 2 PLUS · +6 | — | — |
| DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. | China | Maker | Dental Lithium Disilicate Glass-Ceramic · Dental Zirconia Ceramic | — | — |
| SMD Dental Laboratory | South Korea | Maker | LUXEN Zr, LUXEN Smile | — | — |
| IDS Korea | South Korea | Maker | Porcelain Powder | — | — |
| Proto3000 Inc. | Canada | Maker | Dental Direkt GmbH · Upcera | — | — |
| B and D Dental Corporation | United States | Maker | Origin Beyond Plus · Origin Beyond Plus Hybrid · Origin Beyond Plus Mono · Origin Beyond Plus Multi · +1 | — | — |
| Ceragroup Industries | United States | Maker | C-MIX · Ceratec · CGI · CrystalCeram | — | — |
| Chemichl AG | Liechtenstein | Maker | Authentic · BeCe Press · Ceramics2in1 · InSync · +1 | — | — |
| Orbray Co Ltd | Japan | Maker | LayZir Disc · LAYZIR DISC, SHOFU DISK ZR, LUCENT SUPRA, ZIRCONIA DISC · SHOFU DISK ZR Lucent Supra · Zirconia Disc | — | — |
| Forbes Dental Prosthetics Inc. | Philippines | Maker | FORBES DENTAL | — | — |
| Jiangxi rekonova Dental Materials Co., Ltd. | China | Maker | Dental Zirconia Pre-shaded Block · Zirconia Dental Ceramics | — | — |
| Monde Dental Lab | China | Maker | M crown | — | — |
| BMF Precision, Inc. | United States | Maker | UltraThineer | — | — |
| BMF Tech (Zhuhai) Inc. | China | Maker | BMF, UltraThineer Zirconia Slurry (5Y-B), BMF-5YZ-1.6B | — | — |
| COHO Advanced Materials Tech. Co., Ltd. | Taiwan | Maker | — | — | — |
| Seattle Bioceramics, Inc. | United States | Maker | Purzir | — | — |
| Wohlwend-AG | Liechtenstein | Maker | Vision | — | — |
| Amskorea Co.,ltd | South Korea | Maker | — | — | — |
| Dental Laboratory Milling Supplies LLC, DBA Digital Dental, | United States | Maker | — | — | — |
| Megagen Implant Co., Ltd. | South Korea | Foreign exporter | R2iCE II | 30 | 2026 |
| Harvest Dental Products, LLC | United States | Manufacturer | — | 5 | 2023 |
| Alien Milling Technologies | United States | Contract manufacturer | Alien Extreme · Alien HT · Alien Multi-Layer · Alien Multi-Layer 2 · +3 | 1 | 2024 |
| CAO Group, Inc. | United States | Contract manufacturer | Upcera Lithium Disilicate Glass Ceramic Block | 13 | 2020 |
| Schutz Dental GmbH | Germany | Foreign exporter | — | 7 | 2016 |
| Aurident, Inc. | United States | Contract manufacturer | Delta Zirconia | 1 | 2004 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | Porcelain Etch | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | ENAMIC · IPS E.MAX CAD/IPS E.MAX ZIRCAD · IPS EMPRESS · IPS EMPRESS 2 · +1 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Porcelain | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Dental Blocks CAD/CAM Glass Ceramic | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | POWDER, PORCELAIN | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Porcelain | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | IPS CEREC BLOCKS | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Porcelain | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Powder, Porcelain, Celtra and Cerec Blocks | — | — |
| Zhongshan Miiyen New Material Technology Co., Ltd. | China | Foreign exporter | Dental Ceramic · Dental Lithium Disilicate Glass-Ceramic · Dental Porcelain · Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) · +3 | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | Powder, Porcelain - Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series And Up. CAS Series) · Powder, Porcelain - Upcera Coloring Liquid (I And II) · Powder, Porcelain - Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · Powder, Porcelain - Upcera Dental Zirconia Blank For Aesthetic Restoration · +2 | — | — |
| anaxdent North America | United States | Lister | Soprano · Soprano Surface | — | — |
| Shenzhen Upcera Digital Dental Technology Co., Ltd | China | Foreign exporter | Ceramic Etchant (HF-5 and HF-9) · Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) · DUO,Aevra · Glaze Paster, Glaze Powder, and Glaze Liquid · +4 | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Shenzhen Upcera Dental Technology Co., Ltd | China | Foreign exporter | Dental Zirconia Blank for Aesthetic Restoration · DUO, Aevra · Glaze Paste, Glaze Powder, and Glaze Liquid · Gradual Dental Zirconia Blank · +2 | — | — |
| Purple Dental Tech | United States | Repacker / relabeler | Exquisite Dental Tech · Purple Dental Lab | — | — |
| Pan-Am Dental, Inc. | United States | Contract manufacturer | POWDER, PORCELAIN | — | — |
| Primotec LLC | United States | Repacker / relabeler | Primotec ZRT | — | — |
| Olson Dental Laboratory, Inc. | United States | Repacker / relabeler | Powder, Porcelain | — | — |
| Upcera Dental America Inc. | United States | Repacker / relabeler | Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) · Glaze Paste, Glaze Powder, and Glaze Liquid · POWDER, PORCELAIN · Upcera Coloring Liquid (I and II) · +1 | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Bernard Cervos Societe (B.C.S) S.A.S | France | Foreign exporter | X-Cera Pre-shaded Zirconia Blancks · X-Cera Zirconia Blanks | — | — |
| Press-Master, LLC DBA Aesthetic Press | United States | Repacker / relabeler | AP Volution M · AP Volution S · APVolution S | — | — |
| TD Dental Supply, Inc. | United States | Repacker / relabeler | Upcera Zirconia Block | — | — |
| Yucera Healthcare Tech USA INC | United States | Lister | Dental Glass Ceramics · Dental Zirconia Pre-shaded Block · Zirconia Dental Ceramics | — | — |
| Roland DGA | United States | Lister | Perfit FS Dental Zirconia Fully Sintered Block | — | — |
| Synergy Health AST, LLC | United States | Contract sterilizer | AbbottVasc (CR1) - HT Balance Middleweight | — | — |
| VITA North America | United States | Lister | YZ Multi Translucent | — | — |
| Digital Arches Inc. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 30 Oct 2026 | K262685 | Zirconia Collective 4Y Dental Zirconia Blank | Zirconia Collective, Inc. |
| 29 Oct 2026 | K262756 | Zirconia Dental Ceramics and Staining Solution | Fanen New Materials Technology (Suzhou) Co., Ltd. |
| 21 Oct 2026 | K262980 | INNI-CERA (BCM-W500, BCM-W1000) | DentMedi Co., Ltd. |
| 16 Oct 2026 | K262523 | Amber Arte | Hass Corp. |
| 21 Aug 2026 | K262074 | Any-Zircos | Mediclus Co., Ltd |
| 30 Jul 2026 | K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. |
| 17 Jul 2026 | K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. |
| 30 Jun 2026 | K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy |
| 29 Jun 2026 | K260918 | Zolid Lunaris | Amann Girrbach AG |
| 11 Jun 2026 | K260859 | Rosetta SM, Rosetta SP | Hass Corp. |
| 21 May 2026 | K253191 | DCMhotbond zircon | Dental Creativ Management GmbH |
| 9 Apr 2026 | K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation |
| 30 Mar 2026 | K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co.,Ltd. |
| 10 Mar 2026 | K253953 | IPS e.max Zirconia | Ivoclar Vivadent, AG |
| 30 Jan 2026 | K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. |
| 9 Jan 2026 | K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd |
| 8 Dec 2025 | K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. |
| 3 Sep 2025 | K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. |
| 25 Aug 2025 | K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC |
| 10 Jul 2025 | K250063 | ARENA Star, Galaxy Star | ARUM DENTISTRY Co., Ltd |
| 12 Jun 2025 | K250826 | Multi M Series | DMAX Co., Ltd. |
| 5 Jun 2025 | K251084 | zirkon; structure; LFU shades, stains and glazes | estetic ceram ag |
| 29 May 2025 | K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. |
| 20 May 2025 | K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd |
| 12 May 2025 | K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia |
| 11 Apr 2025 | K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd |
| 14 Mar 2025 | K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd |
| 25 Feb 2025 | K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. |
| 21 Feb 2025 | K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. |
| 5 Dec 2024 | K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co.,Ltd. |
| 20 Nov 2024 | K242521 | Estar-ZE | Osstem Implant Co., Ltd. |
| 13 Nov 2024 | K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co.,Ltd |
| 24 Oct 2024 | K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona, Inc. |
| 24 Oct 2024 | K242458 | ArgenZ MTZ | The Argen Corporation |
| 10 Oct 2024 | K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. |
| 30 Sep 2024 | K241151 | LUXEN 5G | DENTALMAX Co., Ltd |
| 18 Sep 2024 | K233064 | Copra Supreme | Whitepeaks Dental Solutions GmbH |
| 6 Sep 2024 | K241579 | DD Hybridlayer (multicolored zirconia) | Dental Direkt GmbH |
| 30 Aug 2024 | K241602 | Kingcera Dental Zirconia Blank | Hunan Qinghao Puzhong Technology Co., Ltd. |
| 28 Aug 2024 | K241557 | Cercon® yo ML | Dentsply Sirona, Inc. |
| 12 Jul 2024 | K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd |
| 9 Jul 2024 | K241316 | Zirconia Block | Hunan Hualian Special Ceramics Co., Ltd |
| 24 Jun 2024 | K232952 | Copran Zri | Whitepeaks Dental Solutions GmbH |
| 21 Jun 2024 | K233885 | rainbow Paste Stain SE | GENOSS Co., Ltd. |
| 20 Jun 2024 | K233158 | Copra Smile, Copra Supreme Hyperion | Whitepeaks Dental Solutions GmbH |
| 7 Jun 2024 | K240672 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) | Zhejiang Zahndent Biotechnology Co.,Ltd |
| 31 May 2024 | K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | Anhui Miisen Intelligence Technology Co., Ltd. |
| 20 May 2024 | K240772 | Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) | Hunan Ceramaster Material Technology Co., Ltd. |
| 1 May 2024 | K240882 | BruxZir® Esthetic | Prismatik Dentalcraft, Inc. |
| 12 Apr 2024 | K240419 | UltraThineer Zirconia Slurry (5Y-B) | Boston Micro Fabrication |
| 20 Mar 2024 | K240574 | BruxZir® Radiant | Prismatik Dentalcraft, Inc. |
| 19 Mar 2024 | K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. |
| 27 Feb 2024 | K234014 | Obsidian® NOW | Prismatik Dentalcraft, Inc. |
| 23 Feb 2024 | K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | GENOSS Co., Ltd. |
| 23 Jan 2024 | K232676 | Dental Porcelain Powder | Chengdu Besmile Medical Technology Co., Ltd. |
| 23 Jan 2024 | K232673 | Dental Glass Ceramics | Chengdu Besmile Medical Technology Co., Ltd. |
| 12 Jan 2024 | K233125 | Zirconia Block | Hangzhou IVISTA Medical Devices Co., Ltd |
| 21 Dec 2023 | K233016 | Dental Glass Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. |
| 1 Dec 2023 | K232438 | Dental Glass Ceramics Blocks | Aibodent Biotechnology Co., Ltd. |
| 7 Sep 2023 | K231687 | Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd |
| 3 Jul 2023 | K230487 | Dental Lithium Disilicate Glass-Ceramic | Fuzhou Rick Brown Biomaterials Co. Ltd. |
| 30 Jun 2023 | K231264 | Easy On Universal Glaze & Stain | Doctus Global |
| 20 Jun 2023 | K223029 | Perfit CL | Vatech mcis Co., Ltd. |
| 9 Jun 2023 | K231347 | BruxZir TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. |
| 2 Jun 2023 | K222961 | Harvest Conceal ZR Block Out | Harvest Dental Products, LLC |
| 25 May 2023 | K230259 | Soreal Press, Soreal CAD | Shenzhen Up3D Technology Co., Ltd. |
| 16 May 2023 | K230262 | BruxZir Incisal Coloring Liquid | Prismatik Dentalcraft, Inc. |
| 31 Mar 2023 | K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Topzir Biotech Co., Ltd |
| 27 Mar 2023 | K223192 | XT Stain/Glaze | Shenzhen Xiangtong Co., Ltd. |
| 27 Feb 2023 | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | ARUM DENTISTRY Co., Ltd |
| 10 Feb 2023 | K223194 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. |
| 10 Feb 2023 | K222513 | Glass Ceramics | Yilink (Tianjin) Biotechnology Co., Ltd. |
| 14 Dec 2022 | K213722 | ICE Ceramics, ICE Stains, Fresco | Zirkonzahn Srl |
| 6 Dec 2022 | K222626 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd |
| 14 Nov 2022 | K222520 | Zirconia Block | Yilink (Tianjin) Biotechnology Co., Ltd. |
| 6 Oct 2022 | K222686 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. |
| 23 Sep 2022 | K220369 | Esthetic Colorant | Kuraray Noritake Dental, Inc. |
| 2 Aug 2022 | K220816 | BruxZir NOW | Prismatik Dentalcraft, Inc. |
| 29 Jul 2022 | K221242 | Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Hunan Vsmile Biotechnology Co.,Ltd |
| 14 Jul 2022 | K221429 | KDF Zirconia Disc | DENKEN-HIGHDENTAL Co., Ltd. |
| 8 Jul 2022 | K221051 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Changsha Honchon Technology Co., LTD |
| 29 Jun 2022 | K220960 | BruxZir Opaque Coloring Liquid | Prismatik Dentalcraft, Inc. |
| 29 Jun 2022 | K220017 | Coloring Liquid | Dongguan Xiangtong Co., Ltd. |
| 28 Mar 2022 | K213147 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. |
| 18 Mar 2022 | K212939 | Vintage Prime Press | Shofu Inc |
| 18 Feb 2022 | K214005 | Zirconia Dental Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. |
| 18 Feb 2022 | K214003 | Dental Zirconia Pre-shaded Block | Shenzhen Yurucheng Dental Materials Co., Ltd. |
| 7 Jan 2022 | K213570 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd |
| 6 Dec 2021 | K212548 | LUXEN CL Dental Liquid | DENTALMAX Co., Ltd |
| 17 Nov 2021 | K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. |
| 15 Nov 2021 | K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co.,Ltd. |
| 12 Nov 2021 | K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Zirdent New Material Co.,Ltd |
| 4 Oct 2021 | K211308 | INNI-CERA | Aon Co., Ltd. |
| 26 Aug 2021 | K202952 | Amber Mill Q Series & Amber Mill Direct Series | Hass Corp. |
| 20 Aug 2021 | K211916 | IPS e.max One | Ivoclar Vivadent, AG |
| 27 Jul 2021 | K210884 | 1Derful HS, 1Derful HT | 1derful, Inc. |
| 2 Jul 2021 | K210097 | Estar-Z | Osstem Implant Co., Ltd. |
| 1 Jul 2021 | K203672 | MAZIC Claro CAD and MAZIC Claro Press | Vericom Co., Ltd. |
| 24 Jun 2021 | K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. |
| 5 Apr 2021 | K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank | Vatech Acucera, Inc. |
| 10 Mar 2021 | K201492 | Non-Sterile Zirconia Block | Bioden Co., Ltd. |
| 8 Mar 2021 | K203351 | Perfit ZR HT Dental Zirconia blank | Vatech Acucera, Inc. |
| 23 Feb 2021 | K201915 | GenesisZr 4Y+ (ST1100) Zirconia | United Dental Resources Corporation |
| 28 Jan 2021 | K201608 | GenesisZr UHT700 Zirconia | United Dental Resources Corporation |
| 20 Jan 2021 | K202629 | Dentsply Sirona Universal Spray Glazes | Dentsply Sirona, Inc. |
| 10 Dec 2020 | K202673 | X-cera Pre-shaded Zirconia Blanks | Dongguan Xiangtong Co., Ltd. |
| 29 Oct 2020 | K193090 | HCG Zirconia Ceramic Block | Hocheng Corporation |
| 18 Aug 2020 | K192723 | Coloring Liquid | Aidite (Qinhuangdao) Technology Co., Ltd |
| 21 Jul 2020 | K193434 | VITA LUMEX AC | Vita Zahnfabrik GmbH H Rauter & CO |
| 8 Jul 2020 | K192231 | Dental Glass Ceramics Blocks | Aidite (Qinhuangdao) Technology Co., Ltd |
| 10 Jun 2020 | K200131 | BruxZir Steel | Prismatik Dentalcraft, Inc. |
| 29 May 2020 | K192262 | Dental Zirconia Blocks | De Corematrix Co.Ltd. |
| 14 May 2020 | K193436 | VITA Ambria | Vita Zahnfabrik GmbH H Rauter & CO |
| 13 May 2020 | K193055 | Purzir Dental Zirconia | 3DBiocad |
| 16 Apr 2020 | K193588 | DD Contrast | Dental Direkt GmbH |
| 31 Jan 2020 | K192535 | Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia | Qinhuangdao Audental Metal Technology Co., Ltd. |
| 30 Jan 2020 | K193060 | Noritake Super Porcelain EX-3 | Kuraray Noritake Dental, Inc. |
| 15 Jan 2020 | K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA |
| 20 Dec 2019 | K190112 | Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. |
| 22 Nov 2019 | K191903 | BruxZir GT (Gum Tissue) Color | Prismatik Dentalcraft, Inc. |
| 22 Nov 2019 | K190518 | Color Liquid, Vita Liquid | Zirkonzahn Srl |
| 4 Nov 2019 | K191304 | EthanZir Zirconia | Besorah Dental Solutions NZ Limited |
| 1 Nov 2019 | K191631 | ZMAXX Dental Zirconia Blanks | Zmaxx Bioceramics, LLC |
| 11 Oct 2019 | K191902 | Razor, Everest, U&C Liquid | U&C International Co., Ltd. |
| 3 Oct 2019 | K191794 | Vintage Art Universal | Shofu Inc |
| 29 Jul 2019 | K190569 | Shaders ZR | Digital Age Dental Lab |
| 23 May 2019 | K190436 | KATANA Zirconia Block | Kuraray Noritake Dental, Inc. |
| 22 May 2019 | K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. |
| 12 Apr 2019 | K190079 | ArgenZ HT+ | The Argen Corporation |
| 4 Apr 2019 | K183304 | Prettau, ICE, Z-White zirconia blanks | Zirkonzahn Srl |
| 20 Mar 2019 | K183408 | Jensen Shade Effect Liquids | Jensen Industries, Inc. |
| 14 Feb 2019 | K183569 | DD cube ONE ML | Dental Direkt GmbH |
| 8 Feb 2019 | K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | The Argen Corporation |
| 25 Jan 2019 | K182642 | GenesisZr 4Y Zirconia | United Dental Resources Corporation |
| 18 Dec 2018 | K181496 | VINTAGE PRO | Shofu Inc |
| 13 Dec 2018 | K182068 | Erran Dental Zirconia | Hangzhou Erran Technology Co., Ltd. |
| 29 Nov 2018 | K181816 | Ceramic Denture Zirconia Ceramics Block | Qinhuangdao Silide Ceramic Technology Co., Ltd. |
| 15 Nov 2018 | K173971 | K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent | YETI Dentalprodukte GmbH |
| 31 Oct 2018 | K171585 | LUXEN Zr, LUXEN Smile | DENTALMAX Co., Ltd |
| 2 Sep 2018 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Liaoning Upcera Co., Ltd |
| 23 Aug 2018 | K170050 | Z-CAD smile | Metoxit AG |
| 1 Aug 2018 | K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. |
| 24 Apr 2018 | K180252 | Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank | Crown Porcelain Dental Technology Co., Ltd. |
| 8 Mar 2018 | K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid | DMAX Co., Ltd. |
| 13 Dec 2017 | K171167 | Prodigio Stain Powder | Operart, LLC |
| 28 Nov 2017 | K161652 | DIAZIR | Zxtgy (Beijing) Technology Co., Ltd. |
| 17 Nov 2017 | K172761 | New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) | Shanghai New Century Dental Materials Co., Ltd. |
| 14 Nov 2017 | K173410 | n!ce for Planmill | Institut Straumann AG |
| 17 Oct 2017 | K170834 | CERABIEN ZR | Kuraray Noritake Dental, Inc. |
| 20 Sep 2017 | K171876 | Ceramill Zolid HT+ white | Amann Girrbach AG |
| 4 Aug 2017 | K163251 | Life Essence Universal Porcelain System | Blue Sky Bio, LLC |
| 1 Aug 2017 | K170894 | Zirconia Dental Ceramics | Chengdu Besmile Biotechnology Co., Ltd. |
| 1 Aug 2017 | K170885 | DD cubeX2 HS | Dental Direkt GmbH |
| 13 Jul 2017 | K170986 | KATANA Zirconia Block | Kuraray Noritake Dental, Inc. |
| 5 Jun 2017 | K163228 | APVolution System | Aesthetic-Press, LLC |
| 4 May 2017 | K163238 | Eclipse Kiss Zirconia | Ams |
| 2 Mar 2017 | K170420 | n!ce Glass Ceramic Blocks for Amann Girrbach | Institut Straumann AG |
| 24 Feb 2017 | K162888 | Cercon | Dentsply Sirona, Inc. |
| 3 Feb 2017 | K161025 | priti multidisc ZrO2 High Translucent | pritidenta GmbH |
| 26 Jan 2017 | K161219 | Zmaxx T Series | Maxx Digm, Inc. |
| 21 Dec 2016 | K162677 | L- OVC | Rhondium, Ltd. |
| 10 Nov 2016 | K160079 | rainbow Shine | GENOSS Co., Ltd. |
| 19 Oct 2016 | K160203 | ADAMANT ZIRCONIA DISC | Adamant Co., Ltd. |
| 16 Sep 2016 | K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, | Institut Straumann AG |
| 15 Sep 2016 | K152023 | Luminesse Shaded Zirconia SZ | Talladium, Inc. |
| 13 Sep 2016 | K153130 | Initial LiSi Block | GC America Inc. |
| 12 Sep 2016 | K160867 | Pavati Z40.2 Zirconia | Ccri, Inc. |
| 1 Sep 2016 | K161922 | XP202 | 3M Deutschland GmbH |
| 12 Aug 2016 | K161269 | CELTRA Press | Dentsply Sirona, Inc. |
| 27 Jul 2016 | K160367 | Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Nissin-Metec China Co., Ltd. |
| 21 Jul 2016 | K160144 | rainbow LS Block | GENOSS Co., Ltd. |
| 14 Jul 2016 | K160102 | Amber Mill Series and Amber Press Series | Hass Corp. |
| 30 Jun 2016 | K153136 | Initial LiSi Press | GC America Inc. |
| 2 Jun 2016 | K160099 | CEREC SpeedGlaze | Dentsply Sirona, Inc. |
| 20 May 2016 | K152103 | IPS Style Ceram, IPS Style Ceram One, IPS Style Press | Ivoclar Vivadent, AG |
| 15 Apr 2016 | K151731 | Rainbow Paste Stain | GENOSS Co., Ltd. |
| 29 Mar 2016 | K153767 | X-cera Zirconia Blanks | Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. |
| 25 Mar 2016 | K152274 | MSCB-001 | GC America Inc. |
| 29 Jan 2016 | K152247 | ATLANTIS Crown | Dentsply International, Inc. |
| 14 Jan 2016 | K151846 | Rainbow LS Pressing | GENOSS Co., Ltd. |
| 14 Jan 2016 | K151842 | Rainbow Shine | GENOSS Co., Ltd. |
| 8 Jan 2016 | K152392 | VINTAGE LD | Shofu Inc |
| 16 Dec 2015 | K152118 | Zenostar MT, Zenostar Color Liquids | Wieland Dental + Technik GmbH & Co. KG |
| 11 Dec 2015 | K152451 | VINTAGE Art LF | Shofu Inc |
| 4 Dec 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co., Ltd |
| 29 Oct 2015 | K151894 | IPS Ivocolor | Ivoclar Vivadent, AG |
| 29 Oct 2015 | K151875 | Pavati Zirconia | Ccri, Inc. |
| 28 Oct 2015 | K151723 | Rainbow Trans | GENOSS Co., Ltd. |
| 21 Oct 2015 | K152066 | Luminesse Anterior Zirconia AT | Talladium, Inc. |
| 16 Oct 2015 | K151844 | Rainbow Shade | GENOSS Co., Ltd. |
| 8 Oct 2015 | K151490 | PRETTAU ANTERIOR T0 | Zirkonzahn Srl |
| 21 Sep 2015 | K152383 | Ceramill Zolid FX | Emergo Europe Consulting |
| 13 Jul 2015 | K150919 | ArgenZ Esthetic Plus | The Argen Corporation |
| 9 Jul 2015 | K143656 | StarCeram® Z-Nature, StarCeram® Z-Smile | H.C. Starck Ceramics GmbH |
| 2 Jul 2015 | K150872 | BruxZir Anterior Milling Blanks | Prismatik Dentalcraft, Inc. |
| 26 Jun 2015 | K143071 | Nacera Pearl | Doceram Medical Ceramics GmbH |
| 17 Jun 2015 | K140836 | ZIBONE ZIRCONIA BLOCKS | Coho Technology Co., Ltd. |
| 15 Jun 2015 | K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID | Talladium, Inc. |
| 20 May 2015 | K140491 | TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS | Tanaka Dental |
| 6 May 2015 | K150056 | Luxisse+ | Heany Industries, Inc. |
Showing the 200 most recent of 491.
Official records: FDA product classification for EIH · 21 CFR 872.6660.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026