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 Jan 28, 2010
SR PHONARES NHC
K093331
Ivoclar Vivadent, Inc.
Dental · 94d
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 Jan 16, 2004
ARTIC
K033628
Heraeus Kulzer, Inc.
Dental · 58d
Cleared Dec 02, 2002
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035
Ivoclar Vivadent, Inc.
Dental · 81d
Cleared Jul 05, 2001
PREMIUM
K011130
Heraeus Kulzer, Inc.
Dental · 83d
Cleared Mar 27, 2001
WILLI GELLER CREAPEARL
K010160
Jensen Industries, Inc.
Dental · 70d
Cleared Feb 07, 2000
ARTIFICIAL TEETH (ACRYLIC TEETH)
K992854
Masterdent Ltda.
Dental · 167d
Cleared Feb 12, 1999
NATURA DENTURE TEETH
K984134
Davis Schottlander & Davis, Ltd.
Dental · 86d
Cleared Feb 09, 1999
ENIGMA DENTURE TEETH
K984128
Davis Schottlander & Davis, Ltd.
Dental · 83d
Cleared Aug 06, 1996
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456
Ivoclar North America, Inc.
Dental · 42d
Cleared Jun 24, 1993
COMPATIT R
K913582
Wilde-USA, Inc.
Dental · 682d
Cleared Dec 23, 1992
NEW TOOTH MATERIAL
K920684
Dentsply Intl.
Dental · 313d
Cleared Mar 02, 1992
VITAPAN ACRYLIC DENTURE TEETH
K914476
Vident
Dental · 146d
Cleared Feb 03, 1992
DENTURE PLASTIC TEETH,76 ELM
K915276
Nobelpharma USA, Inc.
Dental · 70d
Cleared Oct 31, 1985
AUSTENAL MODIFIED ACRYLIC DENTURE RESIN
K853160
Austenal Dental, Inc.
Dental · 93d

About Product Code ELM - Regulatory Context