Prosthetic devices · 21 CFR 872 Subpart D
Impression Material
FDA device type “Material, Impression”.
- Companies listing it
- 12761 makers
- Brands and models
- 623
- 510(k) clearances
- 40417 in five years
- FDA name
- Material, Impression
510(k) clearances per year, 1976–2026
Companies that list ELW
127 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Aquasil Ulta+ Smart Wetting IMpression Material · Aquasil Ultra Rigid · Aquasil Ultra XLV · Elite Glass · +20 | 148 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | I-Sil · Vinyl Poly Siloxane | 22 | 2026 |
| Voco GmbH | Germany | Maker | Fit Test C&B · Registrado X-tra · V-Posil Heavy Soft Fast · V-Posil Light Fast · +4 | 117 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | Hysil Impression Material · HYSIL Impression Materials (Heavy, Mono and Bite) · HySil Impression Materials (Heavy, Mono, and Bite) · HySil Plus Impression Materials · +1 | 68 | 2026 |
| DiaDent Group International | South Korea | Maker | Dia-X Sil Bite · Dia-X Sil Heavy Body · Dia-X Sil Light Body | 24 | 2026 |
| GC America Inc. | United States | Maker | AIM2 · Aroma Fine · Aroma Fine Plus · Coe Alginate · +37 | 137 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | AlgiNot · Correct Plus · Correct Quick · Correct V.P.S. · +20 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Chromaclone 5 Day Stability · Chromaclone Ortho 5 Day Stability · Chromaclone Putty · Chromaclone PVS (Fast Set) · +12 | 95 | 2026 |
| Kulzer, LLC | United States | Maker | Cuttersil Hardener · Cuttersil Light · CUTTERSIL MUCOSA · Cuttersil Putty Plus · +17 | 37 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | DIM350PTF-02 · DIM50BT-01 · DIM50BT-04 · DIM50HB-01 · +5 | 23 | 2025 |
| Prevest Denpro Limited | India | Maker | Accusil Bite Registration · Accusil Heavy Body · Accusil Light Body · Accusil Monophase · +1 | 7 | 2024 |
| Ivoclar Vivadent, AG | United States | Maker | AccuDent XD Syringe Material · AccuDent XD Tray Material · Virtual · Virtual CADbite | 94 | 2026 |
| Dent4You AG | Switzerland | Maker | Adhesive · Adhesive AC · AFFINIS · JET BITE · +4 | 5 | 2026 |
| Shandong Huge Dental Material Corporation | China | Maker | A-Silicone for Bite Registration · Elastomeric Impression Material | 8 | 2026 |
| Kettenbach GmbH & Co. KG | Germany | Maker | Futar (Futar, Futar D, · Futar D Fast, Futar D Slow, · Futar Scan) Bite Registration · Identium Heavy · +17 | 14 | 2026 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Centrix, Inc. | United States | Maker | GingiTrac | 44 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | Vonflex Heavy, Vonflex Light | 20 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | Acu-Flow · Affinity Crystal Clear Matrix Impression Material · Affinity Multi-Prep Extended Working Time Impression Material · Affinity Quick Bite Registration Material · +13 | 8 | 2026 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | IMICRYL Impression Materials · NICETY · PE Sil · REFLECT · +1 | 5 | 2022 |
| DMP Dental Industry S.A. | Greece | Maker | BONA-BITE · BONA-BITE Air · BONA-BITE Crystal Vision · BONASCAN BITE AIR · +14 | 3 | 2026 |
| Keystone Industries | United States | Maker | Consistency Bite Registration · Consistency Putty · Consistency VPS Impression Material · Plastopaste · +4 | 2 | 2025 |
| Detax GmbH | Germany | Maker | — | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| HDI Inc. | South Korea | Maker | DENU Heavy Body(Regular, Fast) · DENU Light Body(Regular, Fast) · DENU Putty Set(Regular, Fast) | 2 | 2022 |
| Coltene/Whaledent AG | Switzerland | Maker | AFFINIS · Coltex · Coltoflax · HydroXtreme · +10 | 45 | 2022 |
| J. Morita USA, Inc. | United States | Maker | Perfectim Systems | 42 | 2022 |
| Ortho Organizers, Inc. | United States | Maker | TASTES GREAT Alginate Flavoring | 8 | 2025 |
| Dreve Dentamid GmbH | Germany | Maker | Dynax clear · Dynax heavy body · Dynax light · Dynax mono · +2 | 6 | 2025 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Honigum AM Heavy Fast USA · Honigum AM Heavy USA · Honigum AM Light 4x25 USA · Honigum AM Light Fast 4x 25 ml · +40 | 4 | 2022 |
| Vigodent Industria e Comercio Ltda | Brazil | Maker | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print · Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular · Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); · Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | 1 | 2025 |
| B&E KOREA Co., Ltd. | South Korea | Maker | Chemi-SiL Bite-Blu · Chemi-SiL HB · Chemi-SiL LB | 1 | 2024 |
| Chemoment Materials Co.,ltd | China | Maker | Dental Impression Material | 1 | 2022 |
| Cavex Holland BV | Netherlands | Maker | Alginate Plus · Alginoplast · Cavex CA 37 · Cavex CA37 · +18 | 26 | 2015 |
| Sterngold | United States | Maker | Stern Vantage | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Septodont | France | Maker | — | 17 | 2021 |
| Crown Delta Corp. | United States | Maker | VPS Silicone Adhesive | 11 | 2013 |
| Psp Dental Co., Ltd. | United Kingdom | Maker | Alginamine · Ortho Algin · Pro Algin Chromatic Alginate · PSP Super Algin · +1 | 6 | 1986 |
| Hygedent, Inc. | China | Maker | CHROMATIC · HYGECHROMA · HYGEDENT · HYGEMAX · +3 | 4 | 2021 |
| Major Prodotti Dentari S.P.A. | Italy | Maker | Algeniux · Alginkid · Alginmajor · Alginmax · +15 | 3 | 2008 |
| Lascod Spa | Italy | Maker | Alginelle · Alginor · Ghenesyl Body Heavy Fast Set · Ghenesyl Body Heavy Normal Set · +46 | 2 | 2020 |
| Dental Technologies, Inc. | United States | Maker | Alpha-dent Alginate Flavoring · Alpha-Dent Alginate Impression Material · Polysulfide Rubber | 2 | 2013 |
| Manufacturera Dental Continental | Mexico | Maker | Bio-Jel · EDGE Condensation · Max Print · Max Print Cromatico · +3 | 2 | 2001 |
| Dentkist, Inc. | South Korea | Maker | CharmFlex®Bite · CharmFlex®Bite Clear · CharmFlex®Bite Fast · CharmFlex®Denture · +9 | 2 | 2020 |
| HRS Co., Ltd. | South Korea | Maker | Sildent Bite · Sildent Fast Heavy Body · Sildent Fast Light Body · SILDENT HEAVY BODY · +3 | 2 | 2018 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Impression material kit · Impression Material, Elastomeric Impression Material, Light Body VPS Addition Silicone Elastomeric Impression Material | 1 | 2020 |
| Sherpa | South Korea | Maker | Deli Bite Clear · Deli-Boarder · Delikit Bite Registration · Delikit Denture Soft Reliner · +16 | 1 | 2011 |
| Handae Chemical Co., Ltd | South Korea | Maker | Delikit Bite Registration Premium · Delikit Heavy Body Premium · Delikit Light Body Premium · PERFECT BITE · +6 | 1 | 2004 |
| Seilglobal CO., Ltd | South Korea | Maker | DentiAnn Smart Sil | 1 | 2015 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Orthalgenat · Orthalgenat Duo · Orthalgenat Ex | — | — |
| Identa Dental Material GmbH | Germany | Maker | IDENTA Bite Reg | — | — |
| Solventum US LLC | United States | Maker | Impregum Penta Soft MB · VPS Tray Adhesive | — | — |
| Jiangxi Dentalbright Technology Co., Ltd | China | Maker | Dental Impression Material | — | — |
| Prisman GmbH | Germany | Maker | CEREC OPTI SPRAY | — | — |
| Sonrisa | United States | Maker | No Stress Impress PRO | — | — |
| IPB Inc | United States | Maker | — | — | — |
| Laxmi Dental Limited | India | Maker | MATERIAL, IMPRESSION | — | — |
| Sunrise Dental Laboratory, Ltd. | Hong Kong SAR China | Maker | P2 POLYETHER | — | — |
| VANNINI DENTAL INDUSTRY S.r.l. | Italy | Maker | Cromatic | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | — | 56 | 2026 |
| Meta Biomed Co, Ltd | United States | Manufacturer | — | 24 | 2024 |
| American Orthodontics | United States | Contract manufacturer | Impressa/Chrome · Impressa/Sure | 44 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Alginate flavorings · Mydent - Impression and Bite Material | 23 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | Impressiv · Kwik | 27 | 2024 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Smylio | United States | Manufacturer | — | 4 | 2026 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | UltraSil Heavy Body Wash · UltraSil Light Body Wash · UltraSil Putty | 2 | 2025 |
| Sleepcare, LLC | United States | Repacker / relabeler | Daybreak Impression Material Kit | 1 | 2026 |
| GrindGuard Inc | United States | Manufacturer | — | 1 | 2026 |
| Dentamerica | United States | Repacker / relabeler | LYGIN | 4 | 2010 |
| Dharma Research, Inc. | United States | Contract manufacturer | ADS Impression Material · Enthus Impression Material · Sherbet Impression Material | 1 | 2015 |
| Rmo, Inc. | United States | Manufacturer | Ortho-Jel Alginate | 1 | 1990 |
| DMG America, L.L.C. | United States | Contract manufacturer | Material, Impression | 1 | 2013 |
| Wright Health Group | United Kingdom | Manufacturer | — | 1 | 2013 |
| Exacta Dental Products, Inc. | United States | Repacker / relabeler | FRESH Bold Impression Material | 1 | 2006 |
| Olympus Corporation | Japan | Foreign exporter | — | 1 | 2007 |
| Jersey Dental Supplies | United States | Repacker / relabeler | AFFINIS; HydroXtreme; Jet Bite; President Jet light / regular body; President Plus; President Plus Jet · AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL · Aquasil Ultra + Smart Wetting Impression Material · AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL · +24 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dental Cement · Dental Impression · Express · Imoression MAterial · +5 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | A-Silicone Bite Registration Material · Impression Material · JMU Dental Impression Materials | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Braval VPS Impression Material · Impression Material · Patterson Bite Registration · Patterson Braval VPS Putty Impression Material · +2 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | dental · Dental Cement · Dental Impression · Express · +6 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Aquasil Heavy · Aquasil Putty · Aquasil Rigid · Dimension Penta · +10 | — | — |
| Premium Plus Dental | United States | Lister | MATERIAL IMPRESSION | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | Dia-X Sil Bite · Dia-X Sil Heavy Body · Dia-X Sil Light Body | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Aluminum Oxide · Aquasil Ultra · DENMAT PREC JAR · Tray Adhesive | — | — |
| Ortho Dental Lab, LLC | United States | Manufacturer | IMPRESSION KIT · SmileSet Impression Kit | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill VPS Impression Material (Heavy Body, Light Body, Bite Registration, Monophase, Alginate) | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | — | — | — |
| Candid Care Co. | United States | Contract manufacturer | Kettenbach Impression Kt | — | — |
| Dental Brands for Less | Canada | Foreign exporter | Aquasil · Genie Sultan · Jeltrate · Lascod | — | — |
| anaxdent North America | United States | Lister | Celara Extended-Pour Alginate | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Master-Dent | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | — | — | — |
| Signa Medical, Inc. | United States | Repacker / relabeler | Chocolate Bite; Clear Bite; Mega Bite; Vanilla Bite · MATERIAL, IMPRESSION · Splash Max; Splash! | — | — |
| HI Medical Co., Ltd. | South Korea | Foreign exporter | Kulzer · 3M ESPE | — | — |
| Sanicure BV | Netherlands | Foreign exporter | MATERIAL, IMPRESSION | — | — |
| DDS Dentalab | United States | Repacker / relabeler | IMPRESSION MATERIAL | — | — |
| Zapalign LLC | United States | Repacker / relabeler | MATERIAL, IMPRESSION | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | MATERIAL, IMPRESSION | — | — |
| Smilden Biotechnology CO., Ltd. | Taiwan | Foreign exporter | PERFIT | — | — |
| Dental Plus USA, LLC | United States | Repacker / relabeler | Silicone gingival mask | — | — |
| Evolve Dental Technologies, Inc. | United States | Repacker / relabeler | KoR Light Body Wash · KoR Putty Fast Set · KoR Putty Regular Set | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | — | — | — |
| HEXA Dental | United States | Contract manufacturer | — | — | — |
| indigodental GmbH | Germany | Foreign exporter | — | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Reset Technology Corporation | United States | Repacker / relabeler | ResetSmile Impression Kit | — | — |
| TD Dental Supply, Inc. | United States | Repacker / relabeler | RIZHAO HUGE DENTLA INDUSTRY COMPANY, LIMITED | — | — |
| Owl Dental | United States | Repacker / relabeler | Owl Impression Material | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| enCore Laboratory | United States | Manufacturer | — | — | — |
| iSmile Dental Products, Inc. | United States | Repacker / relabeler | iSmile Dental Products | — | — |
| Streamline Dental Laboratory | United States | Repacker / relabeler | — | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Frontier Dental Supply Inc | Canada | Foreign exporter | — | — | — |
| Klarity Medical Products | 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 | — | — | — |
| Tas Medical Supply | United States | Foreign exporter | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 16 Sep 2026 | K254152 | Dia-X Sil Light Body | DiaDent Group International |
| 16 Sep 2026 | K254142 | Dia-X Sil Heavy Body | DiaDent Group International |
| 19 Mar 2026 | K254112 | Dia-X Sil Bite | DiaDent Group International |
| 31 Oct 2025 | K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Industria e Comercio Ltda |
| 27 Jun 2025 | K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4You AG |
| 27 Dec 2024 | K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. |
| 15 Nov 2024 | K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4You AG |
| 13 Feb 2024 | K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E KOREA Co., Ltd. |
| 27 Apr 2023 | K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. |
| 19 Jan 2023 | K213175 | No Stress Impress | No Stress Impress, LLC |
| 15 Dec 2022 | K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | GENOSS Co., Ltd. |
| 7 Nov 2022 | K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | HDI Inc. |
| 9 Sep 2022 | K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) | Prevest Denpro Limited |
| 8 Aug 2022 | K221668 | Dental Impression Material | Chemoment Materials Co.,ltd |
| 11 Feb 2022 | K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. |
| 1 Feb 2022 | K220257 | Permadyne | 3M Deutschland GmbH |
| 13 Jan 2022 | K220097 | PRESIDENT The Original | Coltene/Whaledent AG |
| 28 Jul 2021 | K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. |
| 19 Apr 2021 | K203824 | VPS Impression Material | Hygedent, Inc. |
| 18 Mar 2021 | K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. |
| 8 Oct 2020 | K201483 | Impression Material | Zhengzhou Huaer Electro-optics Technology Co., Ltd. |
| 24 Sep 2020 | K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation |
| 5 May 2020 | K201184 | Lascod Impression Materials | Lascod Spa |
| 30 Jan 2020 | K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. |
| 7 Nov 2019 | K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH |
| 4 Sep 2019 | K191034 | VPS Impression Material | Hygedent, Inc. |
| 28 Nov 2018 | K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | HRS Co., Ltd. |
| 13 Sep 2018 | K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. |
| 12 Jul 2018 | K181011 | AIM2 | GC America Inc. |
| 13 Jun 2018 | K180565 | PEAK NS033CF, PEAK NS017CF | Neosil Co., Ltd. |
| 13 Apr 2018 | K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH |
| 31 Oct 2017 | K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH |
| 26 Jul 2017 | K170812 | HygePLUS Alginate Impression Material | Hygedent, Inc. |
| 7 Jun 2017 | K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. |
| 3 Nov 2016 | K152615 | Vonflex S | Vericom Co., Ltd. |
| 30 Sep 2016 | K161774 | i-Sil | Spident Co., Ltd. |
| 5 Aug 2016 | K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties |
| 30 Jun 2016 | K160441 | Identic and KromaFaze Alginate Dental Impression Materials | Sybron Dental Specialties |
| 27 May 2016 | K152826 | NoCord | Centrix, Inc. |
| 8 Mar 2016 | K152766 | CharmFlex | Dentkist, Inc. |
| 4 Mar 2016 | K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. |
| 30 Nov 2015 | K152518 | Vonflex S Putty | Vericom Co., Ltd. |
| 23 Nov 2015 | K152349 | Star+ VPS Scannable Impression Material | Danville Materials, LLC |
| 28 Oct 2015 | K151535 | Cavex Cream Alginate | Cavex Holland BV |
| 22 Oct 2015 | K152180 | PEAK | Neosil Co., Ltd. |
| 21 Sep 2015 | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. |
| 28 Jul 2015 | K151150 | Elements | Pac-Dent International, Inc. |
| 3 Apr 2015 | K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | Ivoclar Vivadent, AG |
| 23 Feb 2015 | K143382 | DentiAnn Smart Sil | Seilglobal CO., Ltd |
| 4 Dec 2014 | K141092 | MARK3 | Cavex Holland BV |
| 15 Aug 2014 | K140966 | VONFLEX S BITE | Vericom Co., Ltd. |
| 19 Jun 2014 | K132869 | SILDENT | HRS Co., Ltd. |
| 5 Jun 2014 | K140602 | FLASH PENTA MB QUICK, FLASH MB QUICK | 3M Espe AG |
| 28 May 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | Rizhao Huge Dental Industry Co., Ltd. |
| 21 May 2014 | K140074 | HYGEDENT ALGINATE IMPRESSION MATERIAL | Hygedent, Inc. |
| 9 Apr 2014 | K134008 | MD-FLEX HEAVY BODY | Meta Biomed Co, Ltd |
| 7 Mar 2014 | K133527 | SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT | Osstem Germany GmbH |
| 7 Mar 2014 | K133436 | FLASH AR; FLASH AR QUICK | 3M Deutschland GmbH |
| 6 Mar 2014 | K133400 | FLASH BITE | 3M Espe AG |
| 25 Feb 2014 | K132599 | SMILEBOND SYSTEM | Millennium Company, LLC |
| 20 Dec 2013 | K131510 | POLYDIMETHYLSILOXANE IMPRESSION MATERIAL | Blackwell Device Consulting |
| 2 Jul 2013 | K130920 | CORRECT PLUS 1 | Pentron Clinical |
| 30 May 2013 | K131404 | FLASH AR PENTA / FLASH AR PENTA QUICK | 3M Deutschland GmbH |
| 30 May 2013 | K130869 | TAKE 1 ADVANCE | Sybron Dental Specialties |
| 17 May 2013 | K130647 | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML | Heraeus Kulzer, LLC |
| 23 Aug 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | Lascod Spa |
| 25 Jul 2012 | K120914 | FLEXITIME FAST & SCAN LIGHT FLOW | Heraeus Kulzer, LLC |
| 13 Jul 2012 | K113574 | FLEXITIME MONOPHASE PRO SCAN | Heraeus Kulzer, LLC |
| 22 May 2012 | K120013 | TEMPSPAN CLEAR MATRIX | Pentron Clinical |
| 10 May 2012 | K120521 | GC BLUE SILICONE | GC America Inc. |
| 2 May 2012 | K120438 | FLASH (DIFFERENT MATERIALS) | 3M Deutschland GmbH |
| 13 Feb 2012 | K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL | Dentsply International, Inc. |
| 14 Nov 2011 | K113279 | IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT | Kettenbach GmbH & Co. KG |
| 14 Nov 2011 | K113263 | ARGES IMAGING CONTRAST SPRAY | Arges Imaging, Inc. |
| 17 Jun 2011 | K110871 | FIT CHECKER ADVANCED | GC America Inc. |
| 8 Apr 2011 | K110092 | TAKE 1 ADVANCED RIGID TRAY | Sybron Dental Specialties |
| 5 Apr 2011 | K110378 | IMPRESSION COMPOUND | Sybron Dental Specialties |
| 30 Mar 2011 | K103586 | IOS FASTSCAN SPRAY | Ios Technnologies, Inc. |
| 28 Mar 2011 | K110050 | FIT TEST C&B | Voco GmbH |
| 11 Feb 2011 | K103346 | DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY | Sherpa |
| 13 Jan 2011 | K102836 | BONASIL A+ IMPRESSION MATERIALS | Dmp, Ltd. |
| 21 Dec 2010 | K102770 | FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW | Heraeus Kulzer, LLC |
| 8 Dec 2010 | K102739 | HYDROCOLOR 5 | Cascades Device Consulting Associates |
| 10 Nov 2010 | K103164 | VONFLEX HEAVY, VINFLEX LIGHT | Vericom Co., Ltd. |
| 7 Sep 2010 | K101617 | FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL | Heraeus Kulzer, LLC |
| 28 Jan 2010 | K092176 | TAKE 1 ADVANCED RIGID TRAY | Sybron Dental Specialties |
| 7 Oct 2009 | K091613 | TAKE 1 | Sybron Dental Specialties |
| 1 Oct 2009 | K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT | Kettenbach GmbH & Co. KG |
| 16 Sep 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | Danville Materials, LLC |
| 31 Jul 2009 | K091494 | FLEXITIME FLOW | Heraeus Kulzer, LLC |
| 6 May 2009 | K091267 | VONFLEX PUTTY | Vericom Co., Ltd. |
| 26 Mar 2009 | K083739 | HYDRORISE AND HYDROSYSTEM | Dentsply Sirona, Inc. |
| 9 Jan 2009 | K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY | Kettenbach GmbH & Co. KG |
| 5 Dec 2008 | K082591 | FLEXITIME BITE | Heraeus Kulzer, Inc., Dental Products Division |
| 8 Sep 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | Kettenbach GmbH & Co. KG |
| 6 Aug 2008 | K082157 | KETTOSIL AND SILGINAT | Kettenbach GmbH & Co. KG |
| 4 Aug 2008 | K081017 | TEMPLATE AND COUNTER-FIT | Clinician'S Choice Dental Products, Inc. |
| 14 May 2008 | K081084 | COLORISE RIGID | Dentsply Sirona, Inc. |
| 1 May 2008 | K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | Kettenbach GmbH & Co. KG |
| 21 Apr 2008 | K080338 | CUTTERSIL ACTIVATOR UNIVERSAL PLUS | Heraeus Kulzer, LLC |
| 11 Apr 2008 | K080882 | CEREC OPTI SPRAY | Dentsply Sirona, Inc. |
| 26 Mar 2008 | K080514 | PECD-01 AND PECD QUICK-01 | 3M Espe AG Dental Products |
| 14 Mar 2008 | K080130 | OCCLUFAST CAD | Dentsply Sirona, Inc. |
| 10 Mar 2008 | K073475 | SYSTEM PLUS | Continental Dental Laboratory |
| 12 Dec 2007 | K073005 | ELITE GLASS | Dentsply Sirona, Inc. |
| 5 Dec 2007 | K072577 | BISICO IMPRESSION SILICONES & ALGINATES | Bisico GmbH & CO KG |
| 4 Dec 2007 | K072622 | STANDOUT 2 | Sybron Dental Specialties |
| 8 Nov 2007 | K072245 | EMULATE ADVANCED | Cavex Holland BV |
| 22 Jun 2007 | K071192 | BLUGOO HD | Lancer Orthodontics, Inc. |
| 11 May 2007 | K070677 | COLORISE | Dentsply Sirona, Inc. |
| 25 Apr 2007 | K070700 | FREEALGIN | Dentsply Sirona, Inc. |
| 16 Nov 2006 | K062400 | IMPRESSIX, COLORCHANGE ALGINATE | Cavex Holland BV |
| 17 Jul 2006 | K060891 | VIRTUAL | Ivoclar Vivadent, AG |
| 10 Jul 2006 | K061267 | SIMULATE, COLOR CHANGE ALGINATE | Cavex Holland BV |
| 26 Jun 2006 | K061427 | PRE-IMPRESSION CONDITIONING SOLUTION | Dentsply Intl., Inc. |
| 1 Mar 2006 | K053619 | COLORBITE | Dentsply Sirona, Inc. |
| 13 Jan 2006 | K053427 | FRESH, DENTAL IMPRESSION MATERIAL | Exacta Dental Products, Inc. |
| 3 Jan 2006 | K051933 | EXPASYL POWER APPLICATOR | Sybron Dental Specialties |
| 23 Nov 2005 | K052455 | IMPRESSIX | Cavex Holland BV |
| 15 Nov 2005 | K053014 | POLY SILOXANE IMPRESSION MATERIAL | Clinician'S Choice Dental Products, Inc. |
| 8 Nov 2005 | K053018 | POLY SILOXANE IMPRESSION MATERIAL | Millennium Dental International, Inc. |
| 20 Oct 2005 | K052409 | SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL | Sultan Chemists, Inc. |
| 5 Aug 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | Philips Medical Systems International BV |
| 21 Jul 2005 | K051797 | FUTURE WASH/YPS | 3M Espe AG Dental Products |
| 19 Jul 2005 | K050417 | ELITE IMPLANT | Dentsply Sirona, Inc. |
| 15 Jul 2005 | K051424 | HYDROGUM 5 | Dentsply Sirona, Inc. |
| 28 Jun 2005 | K051535 | MODIFICATION TO:REGISTRADO X-TRA | Voco GmbH |
| 23 Jun 2005 | K051243 | JET BLUE BITE | Coltene/Whaledent AG |
| 21 Jun 2005 | K051207 | CAVEX ORTHOTRACE | Cavex Holland BV |
| 15 Apr 2005 | K050604 | KERR VPS IMPRESSION MATERIAL | Sybron Dental Specialties |
| 4 Mar 2005 | K043493 | FUSION PUTTY TYPE | GC America Inc. |
| 18 Feb 2005 | K043054 | GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL | Sultan Chemists, Inc. |
| 9 Feb 2005 | K050013 | RETRACTOFOAM | Coltene/Whaledent AG |
| 27 Jan 2005 | K043471 | FUSION FAST | GC America Inc. |
| 24 Jan 2005 | K043118 | HYDROGUM SOFT | Dentsply Sirona, Inc. |
| 17 Dec 2004 | K042878 | FLEXITIME XTREME | Heraeus Kulzer, LLC |
| 15 Dec 2004 | K043131 | TORPICALGIN | Dentsply Sirona, Inc. |
| 3 Dec 2004 | K042860 | CORRECT DENTAL IMPRESSION MATERIAL | Handae Chemical Co., Ltd |
| 25 Jun 2004 | K041398 | GC FUSION | GC America Inc. |
| 17 Jun 2004 | K041229 | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) | Cosmedent, Inc. |
| 14 May 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | Crown Delta Corp. |
| 25 Mar 2004 | K040053 | PRECISION VPS IMPRESSION MATERIAL | Philips Medical Systems International BV |
| 20 Nov 2003 | K032708 | PLASTALGIN AND PLASTALGIN ORTHO | Septodont |
| 20 Oct 2003 | K032289 | FIT CHECKER II | GC America Inc. |
| 2 Oct 2003 | K031439 | ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) | Harry J. Bosworth Co. |
| 30 Sep 2003 | K032116 | TULIP COLORSWITCH | Cavex Holland BV |
| 11 Aug 2003 | K032001 | POLY Q (GARANT L, PENTA M, PENTA H) | 3M Espe AG Dental Products |
| 3 Jul 2003 | K031484 | STAND OUT | Sybron Dental Specialties |
| 9 May 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | Philips Medical Systems International BV |
| 9 Apr 2003 | K030414 | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL | Sultan Chemists, Inc. |
| 3 Apr 2003 | K030318 | P2 POLYETHER | Heraeus Kulzer, LLC |
| 22 Jan 2003 | K023751 | EXAJET | GC America Inc. |
| 18 Dec 2002 | K024041 | ZETAPLUS SOFT | Dentsply Sirona, Inc. |
| 18 Dec 2002 | K024034 | OCCLUFAST ROCK | Dentsply Sirona, Inc. |
| 13 Dec 2002 | K023466 | TULIP ALGINATE IMPRESSION MATERIAL | Cavex Holland BV |
| 28 Oct 2002 | K022653 | ELITE MONOPHASE | Dentsply Sirona, Inc. |
| 18 Oct 2002 | K022430 | ISO FUNCTIONAL | GC America Inc. |
| 14 Aug 2002 | K022066 | REGISTRADO X-TRA | Voco GmbH |
| 13 May 2002 | K021416 | AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. |
| 10 May 2002 | K021413 | AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. |
| 8 May 2002 | K021410 | AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. |
| 17 Apr 2002 | K020242 | EMULATE FAST SET AND EMULATE REGULAR SET | Cavex Holland BV |
| 29 Jan 2002 | K013859 | RHODIA BITE REGISTRATION MATERIAL | Rhodia, Inc. |
| 1 Nov 2001 | K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | S & C Polymer GmbH |
| 1 Nov 2001 | K012517 | CEREC3 VITABLOCKS | Dentsply Sirona, Inc. |
| 29 Oct 2001 | K013336 | XANTALGIN CRONO | Cavex Holland BV |
| 22 Oct 2001 | K013237 | STATUSBLUE | Dmg USA, Inc. |
| 17 Oct 2001 | K013236 | LUXABITE | Dmg USA, Inc. |
| 10 Oct 2001 | K013140 | RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL | Rhodia, Inc. |
| 10 Oct 2001 | K013129 | RHODIA DENTAL PUTTY IMPRESSION MATERIAL | Rhodia, Inc. |
| 4 Sep 2001 | K012405 | EXTRUDE MODIFIED | Sybron Dental Specialties |
| 4 Sep 2001 | K011785 | NOVEL PRINT CYAN ALGINATES | Manufacturera Dental Continental |
| 19 Jul 2001 | K011452 | CAVEX STABISIL | Cavex Holland BV |
| 16 Jul 2001 | K011419 | CAVEX COLORCHANGE | Cavex Holland BV |
| 13 Jun 2001 | K011450 | SILICONE IMPRESSION MATERIAL | Northeast Resins & Silicones, LLC |
| 23 Apr 2001 | K010994 | TAKE ONE BITE MODIFIED | Sybron Dental Specialties |
| 12 Apr 2001 | K010926 | R-SI-LINE METAL-BITE | R-Dental Dentalerzeugnisse GmbH |
| 1 Mar 2001 | K003808 | TAKE 1 | Sybron Dental Specialties |
| 15 Feb 2001 | K003650 | PERMLASTIC 3 | Sybron Dental Specialties |
| 1 Feb 2001 | K003930 | FLEXTIME MAGNUM 360 | Heraeus Kulzer, LLC |
| 23 Jan 2001 | K003426 | ALGINATE IMPRESSION MATERIAL | Rite-Dent Manufacturing Corp. |
| 10 Aug 2000 | K001655 | PERMLASTIC 2 | Sybron Dental Specialties |
| 9 Aug 2000 | K001414 | KWIKKMODEL | R-Dental Dentalerzeugnisse GmbH |
| 21 Jul 2000 | K001876 | TAKE 1 BITE | Sybron Dental Specialties |
| 5 Jul 2000 | K001218 | CORRECT PLUS | Jeneric/Pentron, Inc. |
| 25 May 2000 | K000686 | KROM-ALGINATE AND ALGINATE PLUS | Cavex Holland BV |
| 13 Apr 2000 | K994027 | ACTIVATOR PASTE | Harry J. Bosworth Co. |
| 11 Apr 2000 | K000878 | HONIGUM | Dmg USA, Inc. |
| 5 Apr 2000 | K000629 | FLEXTIME | Heraeus Kulzer, LLC |
| 5 Apr 2000 | K000595 | DIMENSION PENTA L | Espe Dental AG |
| 30 Mar 2000 | K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK | Espe Dental AG |
| 30 Mar 2000 | K000588 | DIMENSION GARANT L, DIMENSION GARANT L QUICK | Espe Dental AG |
| 8 Feb 2000 | K994172 | CEREC 3 | Dentsply Sirona, Inc. |
| 28 Jan 2000 | K994193 | IMPREGUM PENTA DUOSOFT | Espe Dental AG |
| 28 Jan 2000 | K994192 | IMPREGUM PENTA M MONOSOFT | Espe Dental AG |
| 27 Jan 2000 | K994190 | IMPREGUM GARANT L DUOSOFT | Espe Dental AG |
| 27 Jan 2000 | K994077 | AROMA FINE (NORMAL AND FAST SET) | GC America Inc. |
| 2 Nov 1999 | K992001 | TRAY-LINK | Silicon-Und Composite Spezialitaten GmbH |
| 8 Sep 1999 | K992897 | IMPREGUM PENTA | Espe Dental AG |
| 8 Sep 1999 | K992895 | IMPREGUM F | Espe Dental AG |
Showing the 200 most recent of 404.
Official records: FDA product classification for ELW · 21 CFR 872.3660.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026