Impression materials: manufacturers and brands
61 companies make or specify impression materials among the 127 that list one with FDA, under 623 brand and model names. FDA has issued 404 510(k) clearances in this category, 17 of them in the last five years.
510(k) clearances per year, 1976–2026
Impression material 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 |
|---|---|---|---|---|---|
| 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 | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where impression materials 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 |
|---|---|---|---|---|
| Impression MaterialELW | 2 | 872.3660 | 61 | 404 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Sep 2026 | K254152 | Dia-X Sil Light Body | DiaDent Group International | ELW Impression Material |
| 16 Sep 2026 | K254142 | Dia-X Sil Heavy Body | DiaDent Group International | ELW Impression Material |
| 19 Mar 2026 | K254112 | Dia-X Sil Bite | DiaDent Group International | ELW Impression Material |
| 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 | ELW Impression Material |
| 27 Jun 2025 | K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4You AG | ELW Impression Material |
| 27 Dec 2024 | K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | ELW Impression Material |
| 15 Nov 2024 | K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4You AG | ELW Impression Material |
| 13 Feb 2024 | K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E KOREA Co., Ltd. | ELW Impression Material |
| 27 Apr 2023 | K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | ELW Impression Material |
| 19 Jan 2023 | K213175 | No Stress Impress | No Stress Impress, LLC | ELW Impression Material |
| 15 Dec 2022 | K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | GENOSS Co., Ltd. | ELW Impression Material |
| 7 Nov 2022 | K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | HDI Inc. | ELW Impression Material |
| 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 | ELW Impression Material |
| 8 Aug 2022 | K221668 | Dental Impression Material | Chemoment Materials Co.,ltd | ELW Impression Material |
| 11 Feb 2022 | K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. | ELW Impression Material |
| 1 Feb 2022 | K220257 | Permadyne | 3M Deutschland GmbH | ELW Impression Material |
| 13 Jan 2022 | K220097 | PRESIDENT The Original | Coltene/Whaledent AG | ELW Impression Material |
| 28 Jul 2021 | K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | ELW Impression Material |
| 19 Apr 2021 | K203824 | VPS Impression Material | Hygedent, Inc. | ELW Impression Material |
| 18 Mar 2021 | K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. | ELW Impression Material |
| 8 Oct 2020 | K201483 | Impression Material | Zhengzhou Huaer Electro-optics Technology Co., Ltd. | ELW Impression Material |
| 24 Sep 2020 | K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | ELW Impression Material |
| 5 May 2020 | K201184 | Lascod Impression Materials | Lascod Spa | ELW Impression Material |
| 30 Jan 2020 | K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | ELW Impression Material |
| 7 Nov 2019 | K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH | ELW Impression Material |
| 4 Sep 2019 | K191034 | VPS Impression Material | Hygedent, Inc. | ELW Impression Material |
| 28 Nov 2018 | K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | HRS Co., Ltd. | ELW Impression Material |
| 13 Sep 2018 | K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | ELW Impression Material |
| 12 Jul 2018 | K181011 | AIM2 | GC America Inc. | ELW Impression Material |
| 13 Jun 2018 | K180565 | PEAK NS033CF, PEAK NS017CF | Neosil Co., Ltd. | ELW Impression Material |
| 13 Apr 2018 | K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH | ELW Impression Material |
| 31 Oct 2017 | K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH | ELW Impression Material |
| 26 Jul 2017 | K170812 | HygePLUS Alginate Impression Material | Hygedent, Inc. | ELW Impression Material |
| 7 Jun 2017 | K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | ELW Impression Material |
| 3 Nov 2016 | K152615 | Vonflex S | Vericom Co., Ltd. | ELW Impression Material |
| 30 Sep 2016 | K161774 | i-Sil | Spident Co., Ltd. | ELW Impression Material |
| 5 Aug 2016 | K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties | ELW Impression Material |
| 30 Jun 2016 | K160441 | Identic and KromaFaze Alginate Dental Impression Materials | Sybron Dental Specialties | ELW Impression Material |
| 27 May 2016 | K152826 | NoCord | Centrix, Inc. | ELW Impression Material |
| 8 Mar 2016 | K152766 | CharmFlex | Dentkist, Inc. | ELW Impression Material |