Dental ceramics & zirconia: manufacturers and brands
102 companies make or specify dental ceramics among the 143 that list one with FDA, under 5,853 brand and model names. FDA has issued 530 510(k) clearances in this category, 94 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental ceramic manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| 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 |
| Nobel Biocare Services AG | Switzerland | Maker | NobelProcera Zirconia Bridge · NobelProcera Zirconia Crown | 94 | 2026 |
| 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 · +19 | 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 · +52 | 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 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | PrimaConnex CAD/CAM Abutment System | 7 | 2025 |
| Premier Dental Products Company | United States | Maker | Porcelain Silane | 28 | 2026 |
| Keystone Dental Inc. | United States | Maker | Genesis Dental Implant System · MAX-TL Dental Implant System · PrimaConnex Cad/Cam Abutment System | 7 | 2024 |
| 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 · +23 | 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 | — | — |
| China Dental Outsourcing Inc | China | Maker | PORCELAIN | — | — |
| 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 | — | — |
| Shenzhen Jiahong Dental Technology Co., Ltd | China | Maker | ELL | — | — |
| 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 | — | — |
| HO Chi Minh Branch - Vatech Viet Joint Stock Company | Vietnam | Maker | Lithium disilicate Emax/Lisi crown · Lithium disilicate Emax/Lisi inlay and onlay · Lithium disilicate veneer | — | — |
| 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 | — | — |
| Silgan Unicep | United States | Maker | — | — | — |
| 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 · Tooth bond | — | — |
| 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 · tooth bond | — | — |
| 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 | — | — | — |
| DDS Dentalab | United States | Repacker / relabeler | EMPRESS · OPC · PROCERA · ZIRCONIA | — | — |
| 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 | — | — |
| Arvit Dental Laboratory Inc. | United States | Repacker / relabeler | Teeth, Porcelain | — | — |
| Global Dental Technologies, Inc. | United States | Repacker / relabeler | Artificial Teeth | — | — |
| 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 | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental ceramics are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Porcelain PowderEIH | 2 | 872.6660 | 94 | 491 |
| Porcelain TeethELL | 2 | 872.3920 | 14 | 39 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Oct 2026 | K262685 | Zirconia Collective 4Y Dental Zirconia Blank | Zirconia Collective, Inc. | EIH Porcelain Powder |
| 29 Oct 2026 | K262756 | Zirconia Dental Ceramics and Staining Solution | Fanen New Materials Technology (Suzhou) Co., Ltd. | EIH Porcelain Powder |
| 21 Oct 2026 | K262980 | INNI-CERA (BCM-W500, BCM-W1000) | DentMedi Co., Ltd. | EIH Porcelain Powder |
| 16 Oct 2026 | K262523 | Amber Arte | Hass Corp. | EIH Porcelain Powder |
| 21 Aug 2026 | K262074 | Any-Zircos | Mediclus Co., Ltd | EIH Porcelain Powder |
| 30 Jul 2026 | K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | EIH Porcelain Powder |
| 17 Jul 2026 | K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | EIH Porcelain Powder |
| 30 Jun 2026 | K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | EIH Porcelain Powder |
| 29 Jun 2026 | K260918 | Zolid Lunaris | Amann Girrbach AG | EIH Porcelain Powder |
| 11 Jun 2026 | K260859 | Rosetta SM, Rosetta SP | Hass Corp. | EIH Porcelain Powder |
| 21 May 2026 | K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | EIH Porcelain Powder |
| 9 Apr 2026 | K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | EIH Porcelain Powder |
| 30 Mar 2026 | K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co.,Ltd. | EIH Porcelain Powder |
| 10 Mar 2026 | K253953 | IPS e.max Zirconia | Ivoclar Vivadent, AG | EIH Porcelain Powder |
| 30 Jan 2026 | K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | EIH Porcelain Powder |
| 9 Jan 2026 | K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 8 Dec 2025 | K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | EIH Porcelain Powder |
| 3 Sep 2025 | K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | EIH Porcelain Powder |
| 25 Aug 2025 | K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | EIH Porcelain Powder |
| 10 Jul 2025 | K250063 | ARENA Star, Galaxy Star | ARUM DENTISTRY Co., Ltd | EIH Porcelain Powder |
| 12 Jun 2025 | K250826 | Multi M Series | DMAX Co., Ltd. | EIH Porcelain Powder |
| 5 Jun 2025 | K251084 | zirkon; structure; LFU shades, stains and glazes | estetic ceram ag | EIH Porcelain Powder |
| 29 May 2025 | K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | EIH Porcelain Powder |
| 20 May 2025 | K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd | EIH Porcelain Powder |
| 12 May 2025 | K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | EIH Porcelain Powder |
| 11 Apr 2025 | K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd | EIH Porcelain Powder |
| 14 Mar 2025 | K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd | EIH Porcelain Powder |
| 25 Feb 2025 | K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | EIH Porcelain Powder |
| 21 Feb 2025 | K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | EIH Porcelain Powder |
| 5 Dec 2024 | K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co.,Ltd. | EIH Porcelain Powder |
| 20 Nov 2024 | K242521 | Estar-ZE | Osstem Implant Co., Ltd. | EIH Porcelain Powder |
| 13 Nov 2024 | K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co.,Ltd | EIH Porcelain Powder |
| 24 Oct 2024 | K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona, Inc. | EIH Porcelain Powder |
| 24 Oct 2024 | K242458 | ArgenZ MTZ | The Argen Corporation | EIH Porcelain Powder |
| 10 Oct 2024 | K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. | EIH Porcelain Powder |
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