Product code ELM
- Device name
- Denture, Plastic, Teeth
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3590
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Ivoclar Vivadent, Inc. | 2014-01-14 |
| K122955 | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | Wright Health Group , Ltd. | 2013-03-01 |
| K122925 | NEW STETIC ARTIFICIAL TEETH | New Stetic | 2013-02-12 |
| K122852 | PHYSIOSTAR NFC | Candulor USA, Inc. | 2012-12-06 |
| K121749 | VERACIA | Shofu Dental Corporation | 2012-09-07 |
| K120404 | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | Merz Dental GmbH | 2012-05-21 |
| K120736 | SR PHONARES II | Ivoclar Vivadent, AG | 2012-05-14 |
| K113426 | VERACIA SA | Shofu Dental Corporation | 2012-02-08 |
| K101064 | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | Bredent GmbH & Co. KG | 2010-09-14 |
| K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Huge Dental Material Co., Ltd. | 2010-08-16 |
| K093331 | SR PHONARES NHC | Ivoclar Vivadent, Inc. | 2010-01-28 |
| K092231 | GEBDI TRIBOS 501 | Gebdi Dental-Products GmbH | 2009-11-24 |
| K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | Union Dental S.A./Unidesa.Odi | 2007-05-11 |
| K060720 | CURATIVE DENTAL ACRYLIC TEETH | Curative, LLC | 2006-08-25 |
| K061337 | WIEDENT ESTETIC | Xpdent Corp | 2006-06-07 |
| K060994 | MONDIAL | Heraeus Kulzer, Inc. | 2006-05-22 |
| K060565 | CONDYLAFORM II NFC | Ivoclar Vivadent, Inc. | 2006-05-08 |
| K060507 | VALPLAST YAMAHACHI TEETH | Valplast Intl. Corp. | 2006-04-07 |
| K033628 | ARTIC | Heraeus Kulzer, Inc. | 2004-01-16 |
| K030588 | ARTEGRAL AND POLYSTAR SELECTION | Merz Dental GmbH | 2003-05-07 |
| K023035 | SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER | Ivoclar Vivadent, Inc. | 2002-12-02 |
| K022299 | TRILUX, Z-TONE, ACRY ROCK | Ruthibras Imp. Exp. Com. DE Materiais Odontologico | 2002-10-07 |
| K022300 | ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V | Dental Vipi Ltda | 2002-10-03 |
| 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 | 2002-01-30 |
| K011130 | PREMIUM | Heraeus Kulzer, Inc. | 2001-07-05 |
| K010160 | WILLI GELLER CREAPEARL | Jensen Industries, Inc. | 2001-03-27 |
| K000213 | JELDENT BASIC LINE | J.F. Jelenko & Co. | 2000-04-06 |
| K992854 | ARTIFICIAL TEETH (ACRYLIC TEETH) | Masterdent Ltda. | 2000-02-07 |
| K984134 | NATURA DENTURE TEETH | Davis Schottlander & Davis, Ltd. | 1999-02-12 |
| K984128 | ENIGMA DENTURE TEETH | Davis Schottlander & Davis, Ltd. | 1999-02-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| EPOLCL01D4 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02C4 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02C3 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02C2 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02C1 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02B4 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02B3 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02B2 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02B1 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02A9 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02A4 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02A3 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02A2 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL02A1 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01L3 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01D3 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01D2 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01C4 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01C3 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01C2 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01C1 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01B4 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01B3 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01B2 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01B1 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01A9 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01A4 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01A3 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01A2 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-06-10 |
| EPOLCL01A1 | CROSS LINKED 2 | POLIDENT d.o.o. | 2021-05-18 |