ClearanceBrief
Panels › Dental › Product code ELM · Class 2

Denture, Plastic, Teeth

Regulation 872.3590

0510(k)s in 12 months (55 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in ELM

Decided510(k)Device and applicantCode
Jan 14, 2014K132984SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
Ivoclar Vivadent, Inc.
ELM
Mar 1, 2013K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
Wright Health Group , Ltd.
ELM
Feb 12, 2013K122925NEW STETIC ARTIFICIAL TEETH
New Stetic
ELM
Dec 6, 2012K122852PHYSIOSTAR NFC
Candulor USA, Inc.
ELM
Sep 7, 2012K121749VERACIA
Shofu Dental Corporation
ELM
May 21, 2012K120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
Merz Dental GmbH
ELM
May 14, 2012K120736SR PHONARES II
Ivoclar Vivadent, AG
ELM
Feb 8, 2012K113426VERACIA SA
Shofu Dental Corporation
ELM
Sep 14, 2010K101064BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
Bredent GmbH & Co. KG, DE
ELM
Aug 16, 2010K101029KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
Huge Dental Material Co., Ltd.
ELM
Jan 28, 2010K093331SR PHONARES NHC
Ivoclar Vivadent, Inc.
ELM
Nov 24, 2009K092231GEBDI TRIBOS 501
Gebdi Dental-Products GmbH, DE
ELM
May 11, 2007K070591REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
Union Dental S.A./Unidesa.Odi, ES
ELM
Aug 25, 2006K060720CURATIVE DENTAL ACRYLIC TEETH
Curative, LLC
ELM
Jun 7, 2006K061337WIEDENT ESTETIC
Xpdent Corp
ELM
May 22, 2006K060994MONDIAL
Heraeus Kulzer, Inc.
ELM
May 8, 2006K060565CONDYLAFORM II NFC
Ivoclar Vivadent, Inc.
ELM
Apr 7, 2006K060507VALPLAST YAMAHACHI TEETH
Valplast Intl. Corp.
ELM
Jan 16, 2004K033628ARTIC
Heraeus Kulzer, Inc.
ELM
May 7, 2003K030588ARTEGRAL AND POLYSTAR SELECTION
Merz Dental GmbH
ELM
Dec 2, 2002K023035SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
Ivoclar Vivadent, Inc.
ELM
Oct 7, 2002K022299TRILUX, Z-TONE, ACRY ROCK
Ruthibras Imp. Exp. Com. DE Materiais Odontologico
ELM
Oct 3, 2002K022300ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
Dental Vipi Ltda
ELM
Jan 30, 2002K013824ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH
Dental Manufacturing S.P.A
ELM
Jul 5, 2001K011130PREMIUM
Heraeus Kulzer, Inc.
ELM
Mar 27, 2001K010160WILLI GELLER CREAPEARL
Jensen Industries, Inc.
ELM
Apr 6, 2000K000213JELDENT BASIC LINE
J.F. Jelenko & Co.
ELM
Feb 7, 2000K992854ARTIFICIAL TEETH (ACRYLIC TEETH)
Masterdent Ltda.
ELM
Feb 12, 1999K984134NATURA DENTURE TEETH
Davis Schottlander & Davis, Ltd.
ELM
Feb 9, 1999K984128ENIGMA DENTURE TEETH
Davis Schottlander & Davis, Ltd.
ELM
Aug 6, 1996K962456SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
Ivoclar North America, Inc.
ELM
Jun 13, 1994K933737DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH
Durodent Corp.
ELM
May 16, 1994K936058OPTODENT/OPTOGNATH
Spectrum Healthcare Group
ELM
May 2, 1994K940244VERIDENT PLUS, OPTIFORM
Lactona Corp.
ELM
Feb 17, 1994K926070PRIMODENT ACRYLIC TEETH
I.T.C. Ent.
ELM
Jun 24, 1993K913582COMPATIT R
Wilde-USA, Inc.
ELM
May 27, 1993K931162KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH
King Dental Corp.
ELM
Dec 23, 1992K920684NEW TOOTH MATERIAL
Dentsply Intl.
ELM
Nov 4, 1992K924526DENTURE PLASTIC TEETH
Austenal, Inc.
ELM
Mar 2, 1992K914476VITAPAN ACRYLIC DENTURE TEETH
Vident
ELM
Feb 3, 1992K915276DENTURE PLASTIC TEETH,76 ELM
Nobelpharma USA, Inc.
ELM
Jun 23, 1987K871160TRUETECH MEDICAL, INC. DENTURE CUPS
Zenex Medical, Inc.
ELM
Feb 10, 1987K864707SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH
Ivoclar USA, Inc.
ELM
Oct 31, 1985K853160AUSTENAL MODIFIED ACRYLIC DENTURE RESIN
Austenal Dental, Inc.
ELM
Aug 16, 1985K852981PREFORMED TOOTH ARCH
Swipes Dental Laboratory
ELM
Apr 8, 1985K844670KORVIN VITA RADIOPAQUE PLASTIC TEETH
Credent Co.
ELM
Dec 3, 1984K844349SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS
Ivoclar USA, Inc.
ELM
Jul 31, 1984K842208NATURA-TONE OR LUXOPAL CL ACRYLIC
Parexel Intl. Corp.
ELM
May 9, 1983K831214DELTA TEETH
Dentsply Intl.
ELM
May 5, 1981K810970ISOSIT TEETH
Bauer, Cheng & Associates, Inc.
ELM

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