ELM · Class II · 21 CFR 872.3590

FDA Product Code ELM: Denture, Plastic, Teeth

Leading manufacturers include Ivoclar Vivadent, Inc., Dentsply Intl. and Heraeus Kulzer, Inc..

55
Total
55
Cleared
106d
Avg days
1977
Since

FDA 510(k) Cleared Denture, Plastic, Teeth Devices (Product Code ELM)

55 devices
1–24 of 55
Cleared Jan 14, 2014
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984
Ivoclar Vivadent, Inc.
Dental · 112d
Cleared Mar 01, 2013
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
K122955
Wright Health Group , Ltd.
Dental · 157d
Cleared Feb 12, 2013
NEW STETIC ARTIFICIAL TEETH
K122925
New Stetic
Dental · 141d
Cleared Dec 06, 2012
PHYSIOSTAR NFC
K122852
Candulor USA, Inc.
Dental · 79d
Cleared Sep 07, 2012
VERACIA
K121749
Shofu Dental Corporation
Dental · 85d
Cleared May 21, 2012
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
K120404
Merz Dental GmbH
Dental · 102d
Cleared May 14, 2012
SR PHONARES II
K120736
Ivoclar Vivadent, AG
Dental · 66d
Cleared Feb 08, 2012
VERACIA SA
K113426
Shofu Dental Corporation
Dental · 82d
Cleared Sep 14, 2010
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
K101064
Bredent GmbH & Co. KG
Dental · 151d
Cleared Aug 16, 2010
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
K101029
Huge Dental Material Co., Ltd.
Dental · 125d
Cleared Jan 28, 2010
SR PHONARES NHC
K093331
Ivoclar Vivadent, Inc.
Dental · 94d
Cleared Nov 24, 2009
GEBDI TRIBOS 501
K092231
Gebdi Dental-Products GmbH
Dental · 124d
Cleared May 11, 2007
REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
K070591
Union Dental S.A./Unidesa.Odi
Dental · 71d
Cleared Aug 25, 2006
CURATIVE DENTAL ACRYLIC TEETH
K060720
Curative, LLC
Dental · 161d
Cleared Jun 07, 2006
WIEDENT ESTETIC
K061337
Xpdent Corp
Dental · 26d
Cleared May 22, 2006
MONDIAL
K060994
Heraeus Kulzer, Inc.
Dental · 41d
Cleared May 08, 2006
CONDYLAFORM II NFC
K060565
Ivoclar Vivadent, Inc.
Dental · 66d
Cleared Apr 07, 2006
VALPLAST YAMAHACHI TEETH
K060507
Valplast Intl. Corp.
Dental · 39d
Cleared Jan 16, 2004
ARTIC
K033628
Heraeus Kulzer, Inc.
Dental · 58d
Cleared May 07, 2003
ARTEGRAL AND POLYSTAR SELECTION
K030588
Merz Dental GmbH
Dental · 71d
Cleared Dec 02, 2002
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035
Ivoclar Vivadent, Inc.
Dental · 81d
Cleared Oct 07, 2002
TRILUX, Z-TONE, ACRY ROCK
K022299
Ruthibras Imp. Exp. Com. DE Materiais Odontologico
Dental · 83d
Cleared Oct 03, 2002
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
K022300
Dental Vipi Ltda
Dental · 79d
Cleared Jan 30, 2002
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH
K013824
Dental Manufacturing S.P.A
Dental · 72d

About Product Code ELM - Regulatory Context