Prosthetic devices · 21 CFR 872 Subpart D
Teeth Plastic Denture
FDA device type “Denture, Plastic, Teeth”.
- Companies listing it
- 9161 makers
- Brands and models
- 252
- 510(k) clearances
- 550 in five years
- FDA name
- Denture, Plastic, Teeth
510(k) clearances per year, 1976–2026
Companies that list ELM
91 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Genios | 148 | 2026 |
| Voco GmbH | Germany | Maker | CediTEC DT · V-Print DT | 117 | 2026 |
| Shofu Inc | Japan | Maker | VERACIA · VERACIA SA | 96 | 2025 |
| SprintRay Inc. | United States | Maker | Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) · Crown HT (A1, A2, A3, B1, Unpigmented, Bleach) · Midas Restore (A1, A2, A3, B1, Bleach, Unpigmented, C2) · SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) | 8 | 2026 |
| GC America Inc. | United States | Maker | WILLI GELLER CREAPEARL | 137 | 2026 |
| Kulzer, LLC | United States | Maker | Artic · Artic Digital · Delara · MONDIAL · +1 | 37 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | BlueLine · Bonartic II NFC Plus · BonSelect TCR · Candulor Bonartic TCR · +29 | 94 | 2026 |
| Shandong Huge Dental Material Corporation | China | Maker | IMPLA · KAIBIAO (MAIST) · KAIFENG (Sonning) · KAIJING · +8 | 8 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | POP (Preformed Ovate Pontic) | 7 | 2025 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Maker | VITA VIONIC VIGO · VITAPAN, VITAPAN PLUS, VITAPAN EXCELL, VITAPAN CUSPIFORM | 8 | 2026 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | IMIDENT LUX · PAMA | 5 | 2022 |
| Yamahachi Dental Mfg. Co. | Japan | Maker | Crown NS Efucera NS · Crown PX · Efucera AC · Efucera PX · +5 | 3 | 2026 |
| New Stetic, SA | Colombia | Maker | Alfa-Lux · BabyDent · Biodent · Colossus · +16 | 5 | 2026 |
| bredent GmbH & Co. KG | Germany | Maker | visio.lign color · visio.lign shield | 3 | 2024 |
| Shenzhen Piocreat 3D Technology Co., Ltd | China | Maker | Denture Base Resin(PN-Denture (Red,White)) | 1 | 2024 |
| Merz Dental GmbH | Germany | Maker | artegral HD · artegral, Polystar Selection | 8 | 2017 |
| Davis Schottlander & Davis, Ltd. | United Kingdom | Maker | — | 7 | 2004 |
| Major Prodotti Dentari S.P.A. | Italy | Maker | Bambino Tooth · Major AF Comp · Major Dent · Major Plus · +2 | 3 | 2008 |
| Polident d.o.o. | Slovenia | Maker | Artificial teeth CROSS LINKED 2 · Artificial teeth ICX-ROYAL · Artificial teeth REF-LINE · DD poly Y ML · +2 | 2 | 2016 |
| Union Dental S.A. | Spain | Maker | ELEDENT · NATURE'S BEST · ODIDENT · ODILUX · +6 | 1 | 2015 |
| The Myerson Company Limited | Trinidad & Tobago | Maker | Kenson · Myerson · Swissident | 1 | 2017 |
| Wright Health Group | United Kingdom | Maker | Dentavit · Dentavit Monarch Acrotone Senator Dentorium · Dentoluux · Dentoluux V · +1 | 1 | 2013 |
| Masterdent Ltda. | Colombia | Maker | DAVINCI · RAFAEL · RESISTAL · STARDENT · +2 | 1 | 2000 |
| Blue Dent Dental | Brazil | Maker | Denture, plastic, teeth | 1 | 2018 |
| gebdi Dental Products GmbH | Germany | Maker | — | 1 | 2009 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental Plastic edge | — | — |
| Nanjing Chamlion Laser Technology Co., Ltd. | China | Maker | Synthetic Polymer Teeth(01) · Synthetic Polymer Teeth(02) · Synthetic Polymer Teeth(03) · Synthetic Polymer Teeth(04) · +27 | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Maker | 3D Tooth | — | — |
| one day dental partner | South Korea | Maker | kage Denture, plastic, teeth,print | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | PriZma 3D Bio Crown · PriZma 3D Bio Crown Diamond · PriZma 3D Bio Crown Tough | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Denture, plastic, teeth | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | Teeth shade guide | — | — |
| Improve Co.,limited | Hong Kong SAR China | Maker | arylic dentures | — | — |
| Heyuan Hey White Technology Co., Ltd. | China | Maker | Professional Shade Guide | — | — |
| Evoden Industria Comercio Importacao e Exportacao de Produto | Brazil | Maker | Duodent · Duolut · Ecodent · Evodent · +2 | — | — |
| China Dental Outsourcing Inc | China | Maker | DENTURE · TEETH | — | — |
| Dxin Trading HK Co., Limited | China | Maker | arylic dentures | — | — |
| Huile Denture Technology (Hong Kong) Co Limited | China | Maker | arylic dentures | — | — |
| Smilden Biotechnology CO., Ltd. | Taiwan | Maker | Denture, Plastic, Teeth | — | — |
| DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. | China | Maker | Synthetic resin teeth | — | — |
| Cometech VN Company Limited | Vietnam | Maker | COMETECH VN | — | — |
| Shenzhen Jiahong Dental Technology Co., Ltd | China | Maker | ELM | — | — |
| Shenzhen Yongchanghe Technology Co., Ltd. | China | Maker | Permanent Crown Resin | — | — |
| Xiamen Antinsky Industry Co., Ltd | China | Maker | Permanent Crown Resin | — | — |
| Beijing Yingguan Dental Science&Technology Co.,Ltd. | China | Maker | CAD/CAM frame & partial denture PEEK · CAD/CAM full denture PEEK | — | — |
| Crown Trading (HK) Co., Limited | China | Maker | Denture, Plastic, Teeth | — | — |
| Smile Dental Laboratory Company Limited | China | Maker | Flexible,Partial and Full Denture | — | — |
| VIVI Dental Laboratory | China | Maker | Denture, Plastic, Teeth | — | — |
| Istar dental lab | China | Maker | Acrylic denture: ACD-upper and lower; PRD-upper and lower | — | — |
| Integrity Dental Services LLC | United States | Maker | Denture, Plastic, Teeth | — | — |
| Rite Smile Labs | China | Maker | premade acrylic teeth | — | — |
| Huaxian Yuwei Dental Materials Factory | China | Maker | Yuwei Brand Synthetic Polymer Teeth (Ecostar,Suplar.Neputas,Physioca,Typlus) · Yuwei Brand Synthetic Polymer Teeth (Mercury, Venus, Mars, Jupiter, Saturn, Uranus, Neptune ) | — | — |
| Nuvia MSO | United States | Maker | Nuvia Denture | — | — |
| Nuvia Smiles SAS | Colombia | Maker | Nuvia Smiles Dentures | — | — |
| Perfect crown dental lab | United States | Maker | Denture, plastic, teeth | — | — |
| Enta B.V. | Netherlands | Maker | enta®cryl | — | — |
| Vita Tesco | China | Maker | MFT Teeth | — | — |
| Zingo Digital Dental Lab LLC | United States | Maker | ZiNGO DIGITAL DENTAL LAB | — | — |
| Guangzhou Jinguanqiao Industry Co., Ltd | China | Maker | — | — | — |
| Zelia Dental Lab LLC | United States | Maker | — | — | — |
| Myerson LLC | United States | Contract manufacturer | Kenson · Myerson · Swissident | 1 | 2023 |
| Valplast Intl. Corp. | United States | Manufacturer | Platinum Line | 1 | 2006 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental aligner removal hook · DENTURE BOX · ELASTIC PLACER · plastic retainer case · +1 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Shade Guide | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Synthetic Polymer Teeth | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Denture | — | — |
| Premium Plus Dental | United States | Lister | Denture, plastic teeth | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Plastic Teeth Model | — | — |
| anaxdent North America | United States | Lister | anaxcam The Show | — | — |
| DDS Dentalab | United States | Repacker / relabeler | DENTURE · TEETH | — | — |
| Purple Dental Tech | United States | Repacker / relabeler | Exquisite Dental Tech · Purple Dental Lab | — | — |
| Shaw Dental Laboratories Corp. | United States | Repacker / relabeler | Plastic Denture Tooth | — | — |
| Primotec LLC | United States | Repacker / relabeler | REF-LINE | — | — |
| Olson Dental Laboratory, Inc. | United States | Repacker / relabeler | Teeth | — | — |
| Showcase Dental Lab LLC | United States | Contract manufacturer | Denture, Acrylic Teeth, Denture, Partial Denture | — | — |
| star dental lab | United States | Repacker / relabeler | alloy chrome cobalt base metal for dentures · crown and bridge porcelain teeth · crown and bridge temporary resin · partial and full dentures plastic teeth · +2 | — | — |
| Arvit Dental Laboratory Inc. | United States | Repacker / relabeler | Teeth, Denture, Plastic | — | — |
| Global Dental Technologies, Inc. | United States | Repacker / relabeler | Denture, Plastic, Teeth | — | — |
| Henry Schein Canada, Inc. | Canada | Foreign exporter | DB + POS EACH · DB+ 20 ANT FULL SET · DB+ 20 POS FULL SET · DB+ ANT EACH | — | — |
| Dentac, LLC | United States | Repacker / relabeler | dentac denture · denture | — | — |
| Fire Dental Studio, LLC | United States | Repacker / relabeler | FIRE ELM - Denture, plastic, teeth | — | — |
| Premiere 1 Dental Laboratory, LLC | United States | Repacker / relabeler | Denture, Partial, Acrylic Teeth, Plastic, Plastic Teeth | — | — |
| Gregory Weil Dental Ceramic Studio, Inc. | United States | Repacker / relabeler | Denture | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| TD Dental Supply, Inc. | United States | Repacker / relabeler | KAITONG/ROYAL SYNTHETIC POLYMER TEETH | — | — |
| CeraMax Dental Art, LLC | United States | Repacker / relabeler | Denture | — | — |
| Jack Jack LLC | United States | Lister | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Uhler Dental Products & Solutions LLC | United States | Repacker / relabeler | New Stetic | — | — |
| A.D.L. Dental Lab | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 14 Jan 2014 | K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Ivoclar Vivadent, AG |
| 1 Mar 2013 | K122955 | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | Wright Health Group |
| 12 Feb 2013 | K122925 | NEW STETIC ARTIFICIAL TEETH | New Stetic, SA |
| 6 Dec 2012 | K122852 | PHYSIOSTAR NFC | Candulor USA, Inc. |
| 7 Sep 2012 | K121749 | VERACIA | Shofu Inc |
| 21 May 2012 | K120404 | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | Merz Dental GmbH |
| 14 May 2012 | K120736 | SR PHONARES II | Ivoclar Vivadent, AG |
| 8 Feb 2012 | K113426 | VERACIA SA | Shofu Inc |
| 14 Sep 2010 | K101064 | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | bredent GmbH & Co. KG |
| 16 Aug 2010 | K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Huge Dental Material Co., Ltd. |
| 28 Jan 2010 | K093331 | SR PHONARES NHC | Ivoclar Vivadent, AG |
| 24 Nov 2009 | K092231 | GEBDI TRIBOS 501 | gebdi Dental Products GmbH |
| 11 May 2007 | K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | Union Dental S.A./Unidesa.Odi |
| 25 Aug 2006 | K060720 | CURATIVE DENTAL ACRYLIC TEETH | Curative, LLC |
| 7 Jun 2006 | K061337 | WIEDENT ESTETIC | Xpdent Corp |
| 22 May 2006 | K060994 | MONDIAL | Heraeus Kulzer, LLC |
| 8 May 2006 | K060565 | CONDYLAFORM II NFC | Ivoclar Vivadent, AG |
| 7 Apr 2006 | K060507 | VALPLAST YAMAHACHI TEETH | Valplast Intl. Corp. |
| 16 Jan 2004 | K033628 | ARTIC | Heraeus Kulzer, LLC |
| 7 May 2003 | K030588 | ARTEGRAL AND POLYSTAR SELECTION | Merz Dental GmbH |
| 2 Dec 2002 | K023035 | SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER | Ivoclar Vivadent, AG |
| 7 Oct 2002 | K022299 | TRILUX, Z-TONE, ACRY ROCK | Ruthibras Imp. Exp. Com. DE Materiais Odontologico |
| 3 Oct 2002 | K022300 | ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V | Dental Vipi Ltda |
| 30 Jan 2002 | K013824 | ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH | Dental Manufacturing S.P.A |
| 5 Jul 2001 | K011130 | PREMIUM | Heraeus Kulzer, LLC |
| 27 Mar 2001 | K010160 | WILLI GELLER CREAPEARL | Jensen Industries, Inc. |
| 6 Apr 2000 | K000213 | JELDENT BASIC LINE | J.F. Jelenko & Co., Inc. |
| 7 Feb 2000 | K992854 | ARTIFICIAL TEETH (ACRYLIC TEETH) | Masterdent Ltda. |
| 12 Feb 1999 | K984134 | NATURA DENTURE TEETH | Davis Schottlander & Davis, Ltd. |
| 9 Feb 1999 | K984128 | ENIGMA DENTURE TEETH | Davis Schottlander & Davis, Ltd. |
| 6 Aug 1996 | K962456 | SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH | Ivoclar North America, Inc. |
| 13 Jun 1994 | K933737 | DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH | Durodent Corp. |
| 16 May 1994 | K936058 | OPTODENT/OPTOGNATH | Spectrum Healthcare Group |
| 2 May 1994 | K940244 | VERIDENT PLUS, OPTIFORM | Lactona Corp. |
| 17 Feb 1994 | K926070 | PRIMODENT ACRYLIC TEETH | I.T.C. Ent. |
| 24 Jun 1993 | K913582 | COMPATIT R | Wilde-USA, Inc. |
| 27 May 1993 | K931162 | KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH | King Dental Corp. |
| 23 Dec 1992 | K920684 | NEW TOOTH MATERIAL | Dentsply Intl., Inc. |
| 4 Nov 1992 | K924526 | DENTURE PLASTIC TEETH | Austenal, Inc. |
| 2 Mar 1992 | K914476 | VITAPAN ACRYLIC DENTURE TEETH | Vident |
| 3 Feb 1992 | K915276 | DENTURE PLASTIC TEETH,76 ELM | Nobelpharma USA, Inc. |
| 23 Jun 1987 | K871160 | TRUETECH MEDICAL, INC. DENTURE CUPS | Zenex Medical, Inc. |
| 10 Feb 1987 | K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | Ivoclar USA, Inc. |
| 31 Oct 1985 | K853160 | AUSTENAL MODIFIED ACRYLIC DENTURE RESIN | Austenal Dental, Inc. |
| 16 Aug 1985 | K852981 | PREFORMED TOOTH ARCH | Swipes Dental Laboratory |
| 8 Apr 1985 | K844670 | KORVIN VITA RADIOPAQUE PLASTIC TEETH | Credent Co. |
| 3 Dec 1984 | K844349 | SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS | Ivoclar USA, Inc. |
| 31 Jul 1984 | K842208 | NATURA-TONE OR LUXOPAL CL ACRYLIC | Parexel Intl. Corp. |
| 9 May 1983 | K831214 | DELTA TEETH | Dentsply Intl., Inc. |
| 5 May 1981 | K810970 | ISOSIT TEETH | Bauer, Cheng & Associates, Inc. |
| 12 Nov 1980 | K802492 | REIGNING ARTIFICIAL TEETH | Oki Shiks USA , Ltd. |
| 20 Jun 1980 | K801235 | REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN | Oki Shiks USA , Ltd. |
| 4 Jan 1980 | K792245 | TEETH, DENTURE, PLASTIC | Dentsply Intl., Inc. |
| 15 Mar 1978 | K780217 | ANTERIORS AND POSTERIORS, PLASTIC | Dentsply Intl., Inc. |
| 26 Aug 1977 | K771398 | SHELL VENEER | L.D. Caulk Co. |
Official records: FDA product classification for ELM · 21 CFR 872.3590.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026