Product Code: ELW


Products Classified as ELW

1249Material, ImpressionImpression Material.

Total Product Life Cycle (TPLC) Devices

1249Material, ImpressionImpression Material.

FDA Consensus Standards

Material, Impression [32309]21 CFR §872.3660 πŸ”Ž
Material, Impression [37055]21 CFR §872.3660 πŸ”Ž
Material, Impression [38671]21 CFR §872.3660 πŸ”Ž
Material, Impression [38672]21 CFR §872.3660 πŸ”Ž
Material, Impression [33452]21 CFR §872.3660 πŸ”Ž

Pre-market Notifications for ELW

K220097PRESIDENT The OriginalColtène/Whaledent AG
K213890IMICRYL Impression MaterialsIMICRYL Dis Malzemeleri San. Ve Tic. A.S.
K213244Accusil Dental Impression Materials (Accusil Light Body Regular And Fast Set, Accusil Heavy Body Regular And Fast Set, Accusil Monophase Regular And Fast Set, Accusil Putty Regular And Fast Set, Accusil Bite Registration)Prevest Denpro Limited
K211489Dental Impression MaterialNanchang Dental Bright Technology Co., Ltd
K210041HySil Plus Impression MaterialsOsstem Implant Co., Ltd.
K201684A-Silicone For Bite RegistrationShandong Huge Dental Material Corporation
K201483Impression MaterialZhengzhou Huaer Electro Optics Technology Co., Ltd
K201184Lascod Impression MaterialsLascod Spa
K192941HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd.
K191034VPS Impression MaterialHygedent Inc.
K190571StoneBite And StoneBite ScanDreve Dentamid GmbH
K181604Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent BiteHRS Co., Ltd.
K181236HySil Impression MaterialsOSSTEM IMPLANT CO LTD
K181011AIM2GC America Inc.
K180565PEAK NS033CF, PEAK NS017CFNeosil Co., Ltd

Global Unique Device Identification Database

00366975010056Material, Impression
00366975010070Material, Impression
00366975010049Material, Impression
00366975010063Material, Impression
00366975003300Material, Impression
00366975003270Material, Impression
00366975003263Material, Impression
00366975003249Material, Impression
00366975003232Material, Impression
00366975003225Material, Impression
00366975003218Material, Impression
00366975003201Material, Impression
00366975003195Material, Impression
00366975003171Material, Impression
00366975003164Material, Impression

Maude Adverse Events

TEMPLATE ULTRA QUICK MATRIX MATERIALCLINICIAN'S CHOICE DENTAL PRODUCTS, INC2019-08-19
UNKNOWN AQUASIL IMPRESSION MATERIALDENTSPLY CAULK2019-08-01
AQUASIL POLY-VINYL IMPRESSION MATERIALDENTSPLY, LLC2019-07-05
JELTRATE DUSTLESSDENTSPLY CAULK2019-06-14
JELTRATE DUSTLESSDENTSPLY CAULK2019-06-14
JELTRATE DUSTLESSDENTSPLY CAULK2019-06-14
JELTRATE DUSTLESSDENTSPLY CAULK2019-06-14
JELTRATE DUSTLESSDENTSPLY CAULK2019-06-14
JELTRATE DUSTLESSDENTSPLY CAULK2019-06-14
JELTRATE DUSTLESSDENTSPLY CAULK2019-06-14
JELTRATE DUSTLESSDENTSPLY CAULK2019-06-14
FLEXITIME CORRECT FLOWKULZER GMBH2019-06-13
FLEXITIME CORRECT FLOWKULZER SRL2019-06-11
ALGINATE BASIS2019-05-20
JELTRATE ALGINATE IMPRESSION MATERIAL-FAST SETDENTSPLY CAULK2019-04-12
ALGINATE BASIS, CINNAMON, 25LBORMCO CORPORATION2019-04-11
JELTRATE CHROMA DUSTLESS COLOR CHANGING ALGINATE-FAST SETDENTSPLY CAULK2019-03-25
JELTRATE CHROMA DUSTLESS COLOR CHANGING ALGINATE-FAST SETDENTSPLY CAULK2019-03-25
TROPICALGIN ALGINATEZHERMACK S.P.A.2019-03-06
AQUASIL ULTRA DECA HEAVY FAST SET STANDARD PACK-LIGHT GREENDENTSPLY CAULK2019-03-06
ALGINATE BASISORMCO CORPORATION2019-02-20
ALGINATE BASISORMCO CORPORATION2019-02-12
TROPICALGIN ALGINATEZHERMACK S.P.A.2019-01-04
TROPICALGIN ALGINATEZHERMACK S.P.A.2018-11-16
JELTRATE ALGINATE IMPRESSION MATERIAL-FAST SETDENTSPLY CAULK2018-11-07
UNKNOWN HYDROGUMZHERMACK S.P.A.2018-11-02
FLEXITME MONOPHASEKULZER, LLC2018-09-13
CORRECT PLUSPENTRON CLINICAL2018-08-30
CORRECT PLUS IMPRESSION MATERIALPENTRON / KERR CORPORATION2018-07-27
HYDRORISE LIGHT BODY NORMAL SETZHERMACK S.P.A.2018-07-13
FLEXITIME EASY PUTTYKULZER SRL2018-07-11
FLEXITIME CORRECT FLOWKULZER SRL2018-07-11
TROPICALGIN ALGINATEZHERMACK S.P.A.2018-06-27
AQUASIL ULTRA +DENTSPLY CAULK2018-06-14
KERRKERR2018-05-18
ACCUDENT XD TRAY MATERIALIVOCLAR VIVADENT, INC.2018-03-07
EXA'LENCE REGULAR HEAVY 48 MLGC AMERICA INC.2018-02-27
FLEXITIME MONOPHASEKULZER,LLC2017-10-10
PINKALGIN 5ZHERMACK S.P.A.2017-07-14
FLEXITIME EASY PUTTYHERAEUS KULZER SRL2017-06-27
IMPRESSIX ALGINATE XTRA FASTSETRAINTREE ESSIX INC.2017-06-15
3M ESPE IMPRINT 4 PRELIMINARY PENTA SQ3M DEUTSCHLAND GMBH2017-06-13
FLEXITIMEHERAEUS KULZER SRL2017-06-12
PROVO NOVIL P SOFT FASTHERAEUS KULZER SRL2017-05-02
PROVIL NOVO LHERAEUS KULZER SRL2017-05-02
IMPRINT 4 SUPER QUICK STEP LIGHT3M DEUTSCHLAND GMBH2017-04-22
IMPRINT 4 SUPER QUICK HEAVY3M DEUTSCHLAND GMBH2017-04-22
COLORBITE ROCKZHERMACK S.P.A.2017-04-20
CHROMACLONE COLORCHANGEZHERMACK S.P.A.2017-04-20
3M ESPE IMPREGUM PENTA3M DEUTSCHLAND GMBH2017-04-12

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