Denture, Plastic, Teeth
FDA product code ELM · Class II (moderate risk) · 21 CFR 872.3590 · Dental
55510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Ivoclar Vivadent, Inc. 5
- Dentsply Intl. 4
- Heraeus Kulzer, Inc. 3
- Davis Schottlander & Davis, Ltd. 2
- Merz Dental GmbH 2
- Shofu Dental Corp. 2
- Ivoclar USA, Inc. 2
- Oki Shiks USA , Ltd. 2
- Wright Health Group , Ltd. 1
- Swipes Dental Laboratory 1
- Austenal Dental, Inc. 1
- Nobelpharma USA, Inc. 1
- Vident 1
- Austenal, Inc. 1
- King Dental Corp. 1
- Wilde-USA, Inc. 1
- I.T.C. Ent. 1
- Parexel Intl. Corp. 1
- Spectrum Healthcare Group 1
- Bauer, Cheng & Associates, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132984 | SR Vivodent S, SR Orthotyp S, SR Ortholingual SELM · Traditional | Ivoclar Vivadent, Inc. | 01/14/2014SE |
| K122955 | Dentavit, Monarch, Acrotone, Senator, DentoriumELM · Abbreviated | Wright Health Group , Ltd. | 03/01/2013SE |
| K122925 | New Stetic Artificial TeethELM · Traditional | New Stetic | 02/12/2013SE |
| K122852 | Physiostar NFCELM · Traditional | Candulor USA, Inc. | 12/06/2012SE |
| K121749 | VeraciaELM · Traditional | Shofu Dental Corporation | 09/07/2012SE |
| K120404 | Merz Dental GmbH Artegral HD Preformed Plastic Denture TeethELM · Traditional | Merz Dental GmbH | 05/21/2012SE |
| K120736 | SR Phonares IIELM · Traditional | Ivoclar Vivadent, AG | 05/14/2012SE |
| K113426 | Veracia SAELM · Traditional | Shofu Dental Corporation | 02/08/2012SE |
| K101064 | Bredent Novo.Lign A/ Bredent Novo.Lign PELM · Traditional | Bredent GmbH & Co. KG | 09/14/2010SE |
| K101029 | Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethELM · Traditional | Huge Dental Material Co., Ltd. | 08/16/2010SE |
| K093331 | SR Phonares NHCELM · Traditional | Ivoclar Vivadent, Inc. | 01/28/2010SE |
| K092231 | Gebdi Tribos 501ELM · Traditional | Gebdi Dental-Products GmbH | 11/24/2009SE |
| K070591 | Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic…ELM · Traditional | Union Dental S.A./Unidesa.Odi | 05/11/2007SE |
| K060720 | Curative Dental Acrylic TeethELM · Traditional | Curative, LLC | 08/25/2006SE |
| K061337 | Wiedent EsteticELM · Traditional | Xpdent Corp | 06/07/2006SE |
| K060994 | MondialELM · Traditional | Heraeus Kulzer, Inc. | 05/22/2006SE |
| K060565 | Condylaform II NFCELM · Traditional | Ivoclar Vivadent, Inc. | 05/08/2006SE |
| K060507 | Valplast Yamahachi TeethELM · Traditional | Valplast Intl. Corp. | 04/07/2006SE |
| K033628 | ArticELM · Traditional | Heraeus Kulzer, Inc. | 01/16/2004SE |
| K030588 | Artegral and Polystar SelectionELM · Traditional | Merz Dental GmbH | 05/07/2003SE |
| K023035 | SR Vivotac/Sr Orthotac, Modifier Monomer & PolymerELM · Traditional | Ivoclar Vivadent, Inc. | 12/02/2002SE |
| K022299 | Trilux, Z-Tone, Acry RockELM · Traditional | Ruthibras Imp. Exp. Com. DE Materiais Odontologico | 10/07/2002SE |
| K022300 | Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi…ELM · Traditional | Dental Vipi Ltda | 10/03/2002SE |
| K013824 | Acry Plus, Acry Lux, Acry Lux V, Acry Rock, Acry Rock V and Z-Tone Preformed Plastic…ELM · Traditional | Dental Manufacturing S.P.A | 01/30/2002SE |
| K011130 | PremiumELM · Traditional | Heraeus Kulzer, Inc. | 07/05/2001SE |
| K010160 | Willi Geller CreapearlELM · Traditional | Jensen Industries, Inc. | 03/27/2001SE |
| K000213 | Jeldent Basic LineELM · Traditional | J.F. Jelenko & Co. | 04/06/2000SE |
| K992854 | Artificial Teeth (Acrylic Teeth)ELM · Traditional | Masterdent Ltda. | 02/07/2000SE |
| K984134 | Natura Denture TeethELM · Traditional | Davis Schottlander & Davis, Ltd. | 02/12/1999SE |
| K984128 | Enigma Denture TeethELM · Traditional | Davis Schottlander & Davis, Ltd. | 02/09/1999SE |
| K962456 | SR Antaris Anterior Teeth/Sr Postaris Posterior TeethELM · Traditional | Ivoclar North America, Inc. | 08/06/1996SE |
| K933737 | Durodent Corporation Artificial Plastic TeethELM · Traditional | Durodent Corp. | 06/13/1994SE |
| K936058 | Optodent/OptognathELM · Traditional | Spectrum Healthcare Group | 05/16/1994SE |
| K940244 | Verident Plus, OptiformELM · Traditional | Lactona Corp. | 05/02/1994SE |
| K926070 | Primodent Acrylic TeethELM · Traditional | I.T.C. Ent. | 02/17/1994SE |
| K913582 | Compatit RELM · Traditional | Wilde-USA, Inc. | 06/24/1993SE |
| K931162 | King-Hue, Royal Coral, Super-C Artificial TeethELM · Traditional | King Dental Corp. | 05/27/1993SE |
| K920684 | New Tooth MaterialELM · Traditional | Dentsply Intl. | 12/23/1992SE |
| K924526 | Denture Plastic TeethELM · Traditional | Austenal, Inc. | 11/04/1992SE |
| K914476 | Vitapan Acrylic Denture TeethELM · Traditional | Vident | 03/02/1992SE |
| K915276 | Denture Plastic TEETH,76 ElmELM · Traditional | Nobelpharma USA, Inc. | 02/03/1992SE |
| K871160 | Truetech Medical, Inc. Denture CupsELM · Traditional | Zenex Medical, Inc. | 06/23/1987SE |
| K864707 | Sr-Vivodent Anterior & Sr-Orthotyp Posterior TeethELM · Traditional | Ivoclar USA, Inc. | 02/10/1987SE |
| K853160 | Austenal Modified Acrylic Denture ResinELM · Traditional | Austenal Dental, Inc. | 10/31/1985SE |
| K852981 | Preformed Tooth ArchELM · Traditional | Swipes Dental Laboratory | 08/16/1985SE |
| K844670 | Korvin Vita Radiopaque Plastic TeethELM · Traditional | Credent Co. | 04/08/1985SE |
| K844349 | SR Vivodent Pe Anterior Teeth & SR Orthotyp Re PosELM · Traditional | Ivoclar USA, Inc. | 12/03/1984SE |
| K842208 | Natura-Tone or Luxopal CL AcrylicELM · Traditional | Parexel Intl. Corp. | 07/31/1984SE |
| K831214 | Delta TeethELM · Traditional | Dentsply Intl. | 05/09/1983SE |
| K810970 | Isosit TeethELM · Traditional | Bauer, Cheng & Associates, Inc. | 05/05/1981SE |
| K802492 | Reigning Artificial TeethELM · Traditional | Oki Shiks USA , Ltd. | 11/12/1980SE |
| K801235 | Reigning Artificial Teeth/Polycarb.ResinELM · Traditional | Oki Shiks USA , Ltd. | 06/20/1980SE |
| K792245 | Teeth, Denture, PlasticELM · Traditional | Dentsply Intl. | 01/04/1980SE |
| K780217 | Anteriors and Posteriors, PlasticELM · Traditional | Dentsply Intl. | 03/15/1978SE |
| K771398 | Shell VeneerELM · Traditional | L.D. Caulk Co. | 08/26/1977SE |