Atlas FDA

ELM

55 FDA 510(k) clearances · Product code

80 daysmedian time to decision
161 days90th percentile
55clearances measured

FDA profile

Official device name
Denture, Plastic, Teeth
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3590
Medical specialty
Dental
Adverse events (MAUDE)
1997: 1 · 1999: 1 · 2000: 1 · 2013: 43
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S (K132984)Ivoclar Vivadent, Inc.2014-01-14
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM (K122955)Wright Health Group , Ltd.2013-03-01
NEW STETIC ARTIFICIAL TEETH (K122925)New Stetic2013-02-12
PHYSIOSTAR NFC (K122852)Candulor USA, Inc.2012-12-06
VERACIA (K121749)Shofu Dental Corporation2012-09-07
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH (K120404)Merz Dental GmbH2012-05-21
SR PHONARES II (K120736)Ivoclar Vivadent, AG2012-05-14
VERACIA SA (K113426)Shofu Dental Corporation2012-02-08
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (K101064)Bredent GmbH & Co. KG2010-09-14
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH (K101029)Huge Dental Material Co., Ltd.2010-08-16
SR PHONARES NHC (K093331)Ivoclar Vivadent, Inc.2010-01-28
GEBDI TRIBOS 501 (K092231)Gebdi Dental-Products GmbH2009-11-24
REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH (K070591)Union Dental S.A./Unidesa.Odi2007-05-11
CURATIVE DENTAL ACRYLIC TEETH (K060720)Curative, LLC2006-08-25
WIEDENT ESTETIC (K061337)Xpdent Corp2006-06-07
MONDIAL (K060994)Heraeus Kulzer, Inc.2006-05-22
CONDYLAFORM II NFC (K060565)Ivoclar Vivadent, Inc.2006-05-08
VALPLAST YAMAHACHI TEETH (K060507)Valplast Intl. Corp.2006-04-07
ARTIC (K033628)Heraeus Kulzer, Inc.2004-01-16
ARTEGRAL AND POLYSTAR SELECTION (K030588)Merz Dental GmbH2003-05-07
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER (K023035)Ivoclar Vivadent, Inc.2002-12-02
TRILUX, Z-TONE, ACRY ROCK (K022299)Ruthibras Imp. Exp. Com. DE Materiais Odontologico2002-10-07
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V (K022300)Dental Vipi Ltda2002-10-03
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH (K013824)Dental Manufacturing S.P.A2002-01-30
PREMIUM (K011130)Heraeus Kulzer, Inc.2001-07-05
WILLI GELLER CREAPEARL (K010160)Jensen Industries, Inc.2001-03-27
JELDENT BASIC LINE (K000213)J.F. Jelenko & Co.2000-04-06
ARTIFICIAL TEETH (ACRYLIC TEETH) (K992854)Masterdent Ltda.2000-02-07
NATURA DENTURE TEETH (K984134)Davis Schottlander & Davis, Ltd.1999-02-12
ENIGMA DENTURE TEETH (K984128)Davis Schottlander & Davis, Ltd.1999-02-09
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH (K962456)Ivoclar North America, Inc.1996-08-06
DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH (K933737)Durodent Corp.1994-06-13
OPTODENT/OPTOGNATH (K936058)Spectrum Healthcare Group1994-05-16
VERIDENT PLUS, OPTIFORM (K940244)Lactona Corp.1994-05-02
PRIMODENT ACRYLIC TEETH (K926070)I.T.C. Ent.1994-02-17
COMPATIT R (K913582)Wilde-USA, Inc.1993-06-24
KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH (K931162)King Dental Corp.1993-05-27
NEW TOOTH MATERIAL (K920684)Dentsply Intl.1992-12-23
DENTURE PLASTIC TEETH (K924526)Austenal, Inc.1992-11-04
VITAPAN ACRYLIC DENTURE TEETH (K914476)Vident1992-03-02
DENTURE PLASTIC TEETH,76 ELM (K915276)Nobelpharma USA, Inc.1992-02-03
TRUETECH MEDICAL, INC. DENTURE CUPS (K871160)Zenex Medical, Inc.1987-06-23
SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH (K864707)Ivoclar USA, Inc.1987-02-10
AUSTENAL MODIFIED ACRYLIC DENTURE RESIN (K853160)Austenal Dental, Inc.1985-10-31
PREFORMED TOOTH ARCH (K852981)Swipes Dental Laboratory1985-08-16
KORVIN VITA RADIOPAQUE PLASTIC TEETH (K844670)Credent Co.1985-04-08
SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS (K844349)Ivoclar USA, Inc.1984-12-03
NATURA-TONE OR LUXOPAL CL ACRYLIC (K842208)Parexel Intl. Corp.1984-07-31
DELTA TEETH (K831214)Dentsply Intl.1983-05-09
ISOSIT TEETH (K810970)Bauer, Cheng & Associates, Inc.1981-05-05
REIGNING ARTIFICIAL TEETH (K802492)Oki Shiks USA , Ltd.1980-11-12
REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN (K801235)Oki Shiks USA , Ltd.1980-06-20
TEETH, DENTURE, PLASTIC (K792245)Dentsply Intl.1980-01-04
ANTERIORS AND POSTERIORS, PLASTIC (K780217)Dentsply Intl.1978-03-15
SHELL VENEER (K771398)L.D. Caulk Co.1977-08-26

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Every clearance here is in the API, with alerts when new ones post.