FDA Product Code
FDA Product Code ELM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3590
510(k) Clearances — 55 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Ivoclar Vivadent, Inc. | 2014-01-14 | Traditional | PDF ↗ |
| K122955 | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | Wright Health Group , Ltd. | 2013-03-01 | Abbreviated | PDF ↗ |
| K122925 | NEW STETIC ARTIFICIAL TEETH | New Stetic | 2013-02-12 | Traditional | PDF ↗ |
| K122852 | PHYSIOSTAR NFC | Candulor USA, Inc. | 2012-12-06 | Traditional | PDF ↗ |
| K121749 | VERACIA | Shofu Dental Corporation | 2012-09-07 | Traditional | PDF ↗ |
| K120404 | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | Merz Dental GmbH | 2012-05-21 | Traditional | PDF ↗ |
| K120736 | SR PHONARES II | Ivoclar Vivadent, AG | 2012-05-14 | Traditional | PDF ↗ |
| K113426 | VERACIA SA | Shofu Dental Corporation | 2012-02-08 | Traditional | PDF ↗ |
| K101064 | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | Bredent GmbH & Co. KG | 2010-09-14 | Traditional | PDF ↗ |
| K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Huge Dental Material Co., Ltd. | 2010-08-16 | Traditional | PDF ↗ |
| K093331 | SR PHONARES NHC | Ivoclar Vivadent, Inc. | 2010-01-28 | Traditional | PDF ↗ |
| K092231 | GEBDI TRIBOS 501 | Gebdi Dental-Products GmbH | 2009-11-24 | Traditional | PDF ↗ |
| K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | Union Dental S.A./Unidesa.Odi | 2007-05-11 | Traditional | PDF ↗ |
| K060720 | CURATIVE DENTAL ACRYLIC TEETH | Curative, LLC | 2006-08-25 | Traditional | PDF ↗ |
| K061337 | WIEDENT ESTETIC | Xpdent Corp | 2006-06-07 | Traditional | PDF ↗ |
| K060994 | MONDIAL | Heraeus Kulzer, Inc. | 2006-05-22 | Traditional | PDF ↗ |
| K060565 | CONDYLAFORM II NFC | Ivoclar Vivadent, Inc. | 2006-05-08 | Traditional | PDF ↗ |
| K060507 | VALPLAST YAMAHACHI TEETH | Valplast Intl. Corp. | 2006-04-07 | Traditional | PDF ↗ |
| K033628 | ARTIC | Heraeus Kulzer, Inc. | 2004-01-16 | Traditional | PDF ↗ |
| K030588 | ARTEGRAL AND POLYSTAR SELECTION | Merz Dental GmbH | 2003-05-07 | Traditional | PDF ↗ |
| K023035 | SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER | Ivoclar Vivadent, Inc. | 2002-12-02 | Traditional | PDF ↗ |
| K022299 | TRILUX, Z-TONE, ACRY ROCK | Ruthibras Imp. Exp. Com. DE Materiais Odontologico | 2002-10-07 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K011130 | PREMIUM | Heraeus Kulzer, Inc. | 2001-07-05 | Traditional | PDF ↗ |
| K010160 | WILLI GELLER CREAPEARL | Jensen Industries, Inc. | 2001-03-27 | Traditional | PDF ↗ |
| K000213 | JELDENT BASIC LINE | J.F. Jelenko & Co. | 2000-04-06 | Traditional | PDF ↗ |
| K992854 | ARTIFICIAL TEETH (ACRYLIC TEETH) | Masterdent Ltda. | 2000-02-07 | Traditional | PDF ↗ |
| K984134 | NATURA DENTURE TEETH | Davis Schottlander & Davis, Ltd. | 1999-02-12 | Traditional | PDF ↗ |
| K984128 | ENIGMA DENTURE TEETH | Davis Schottlander & Davis, Ltd. | 1999-02-09 | Traditional | PDF ↗ |
| K962456 | SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH | Ivoclar North America, Inc. | 1996-08-06 | Traditional | PDF ↗ |
| K933737 | DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH | Durodent Corp. | 1994-06-13 | Traditional | PDF ↗ |
| K936058 | OPTODENT/OPTOGNATH | Spectrum Healthcare Group | 1994-05-16 | Traditional | PDF ↗ |
| K940244 | VERIDENT PLUS, OPTIFORM | Lactona Corp. | 1994-05-02 | Traditional | PDF ↗ |
| K926070 | PRIMODENT ACRYLIC TEETH | I.T.C. Ent. | 1994-02-17 | Traditional | PDF ↗ |
| K913582 | COMPATIT R | Wilde-USA, Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K931162 | KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH | King Dental Corp. | 1993-05-27 | Traditional | PDF ↗ |
| K920684 | NEW TOOTH MATERIAL | Dentsply Intl. | 1992-12-23 | Traditional | PDF ↗ |
| K924526 | DENTURE PLASTIC TEETH | Austenal, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K914476 | VITAPAN ACRYLIC DENTURE TEETH | Vident | 1992-03-02 | Traditional | PDF ↗ |
| K915276 | DENTURE PLASTIC TEETH,76 ELM | Nobelpharma USA, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K871160 | TRUETECH MEDICAL, INC. DENTURE CUPS | Zenex Medical, Inc. | 1987-06-23 | Traditional | PDF ↗ |
| K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | Ivoclar USA, Inc. | 1987-02-10 | Traditional | PDF ↗ |
| K853160 | AUSTENAL MODIFIED ACRYLIC DENTURE RESIN | Austenal Dental, Inc. | 1985-10-31 | Traditional | PDF ↗ |
| K852981 | PREFORMED TOOTH ARCH | Swipes Dental Laboratory | 1985-08-16 | Traditional | PDF ↗ |
| K844670 | KORVIN VITA RADIOPAQUE PLASTIC TEETH | Credent Co. | 1985-04-08 | Traditional | PDF ↗ |
| K844349 | SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS | Ivoclar USA, Inc. | 1984-12-03 | Traditional | PDF ↗ |
| K842208 | NATURA-TONE OR LUXOPAL CL ACRYLIC | Parexel Intl. Corp. | 1984-07-31 | Traditional | PDF ↗ |
| K831214 | DELTA TEETH | Dentsply Intl. | 1983-05-09 | Traditional | PDF ↗ |
| K810970 | ISOSIT TEETH | Bauer, Cheng & Associates, Inc. | 1981-05-05 | Traditional | PDF ↗ |
| K802492 | REIGNING ARTIFICIAL TEETH | Oki Shiks USA , Ltd. | 1980-11-12 | Traditional | PDF ↗ |
| K801235 | REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN | Oki Shiks USA , Ltd. | 1980-06-20 | Traditional | PDF ↗ |
| K792245 | TEETH, DENTURE, PLASTIC | Dentsply Intl. | 1980-01-04 | Traditional | PDF ↗ |
| K780217 | ANTERIORS AND POSTERIORS, PLASTIC | Dentsply Intl. | 1978-03-15 | Traditional | PDF ↗ |
| K771398 | SHELL VENEER | L.D. Caulk Co. | 1977-08-26 | Traditional | PDF ↗ |
Product code ELM · Class II · Dental. Data: openFDA.