FDA 510(k) Applications for Medical Device Product Code "ELM"
(Denture, Plastic, Teeth)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K101064 | BREDENT GMBH & CO.KG | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | 09/14/2010 |
| K122852 | CANDULOR USA, INC. | PHYSIOSTAR NFC | 12/06/2012 |
| K060720 | CURATIVE, LLC | CURATIVE DENTAL ACRYLIC TEETH | 08/25/2006 |
| K984128 | DAVIS SCHOTTLANDER & DAVIS, LTD. | ENIGMA DENTURE TEETH | 02/09/1999 |
| K984134 | DAVIS SCHOTTLANDER & DAVIS, LTD. | NATURA DENTURE TEETH | 02/12/1999 |
| K013824 | DENTAL MANUFACTURING S.P.A | ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH | 01/30/2002 |
| K022300 | DENTAL VIPI LTDA | ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V | 10/03/2002 |
| K092231 | GEBDI DENTAL-PRODUCTS GMBH | GEBDI TRIBOS 501 | 11/24/2009 |
| K033628 | HERAEUS KULZER, INC. | ARTIC | 01/16/2004 |
| K060994 | HERAEUS KULZER, INC. | MONDIAL | 05/22/2006 |
| K011130 | HERAEUS KULZER, INC. | PREMIUM | 07/05/2001 |
| K101029 | HUGE DENTAL MATERIAL CO., LTD. | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | 08/16/2010 |
| K962456 | IVOCLAR NORTH AMERICA, INC. | SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH | 08/06/1996 |
| K120736 | IVOCLAR VIVADENT AG | SR PHONARES II | 05/14/2012 |
| K060565 | IVOCLAR VIVADENT, INC. | CONDYLAFORM II NFC | 05/08/2006 |
| K093331 | IVOCLAR VIVADENT, INC. | SR PHONARES NHC | 01/28/2010 |
| K132984 | IVOCLAR VIVADENT, INC. | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | 01/14/2014 |
| K023035 | IVOCLAR VIVADENT, INC. | SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER | 12/02/2002 |
| K000213 | J.F. JELENKO & CO. | JELDENT BASIC LINE | 04/06/2000 |
| K010160 | JENSEN INDUSTRIES, INC. | WILLI GELLER CREAPEARL | 03/27/2001 |
| K992854 | MASTERDENT LTDA. | ARTIFICIAL TEETH (ACRYLIC TEETH) | 02/07/2000 |
| K030588 | MERZ DENTAL GMBH | ARTEGRAL AND POLYSTAR SELECTION | 05/07/2003 |
| K120404 | MERZ DENTAL GMBH | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | 05/21/2012 |
| K122925 | NEW STETIC | NEW STETIC ARTIFICIAL TEETH | 02/12/2013 |
| K022299 | RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO | TRILUX, Z-TONE, ACRY ROCK | 10/07/2002 |
| K121749 | SHOFU DENTAL CORPORATION | VERACIA | 09/07/2012 |
| K113426 | SHOFU DENTAL CORPORATION | VERACIA SA | 02/08/2012 |
| K070591 | UNION DENTAL S.A./UNIDESA.ODI | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | 05/11/2007 |
| K060507 | VALPLAST INTL. CORP. | VALPLAST YAMAHACHI TEETH | 04/07/2006 |
| K122955 | WRIGHT HEALTH GROUP LTD. | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | 03/01/2013 |
| K061337 | XPDENT CORP. | WIEDENT ESTETIC | 06/07/2006 |
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