Product Code: EMA


Products Classified as EMA

1252Cement, DentalDental Cement.

Total Product Life Cycle (TPLC) Devices

1252Cement, DentalDental Cement.

FDA Consensus Standards

Cement, Dental [32309]21 CFR §872.3275 🔎
Cement, Dental [35790]21 CFR §872.3275 🔎
Cement, Dental [35831]21 CFR §872.3275 🔎
Cement, Dental [31732]21 CFR §872.3275 🔎
Cement, Dental [32841]21 CFR §872.3275 🔎
Cement, Dental [31725]21 CFR §872.3275 🔎

Pre-market Notifications for EMA

K222253GlasIonomer FX ULTRAShofu Dental Corporation
K220640Bifix Hybrid Abutment CementVOCO GmbH
K213201DeltaFil, DeltaFil ConditionerDMG Chemisch-Pharmazeutische Fabrik GmbH
K211237UltraTemp Rez IIUltradent Products, Inc.
K210504PANAVIA Veneer LCKuraray Noritake Dental Inc.
K210259Parkell Self-Adhesive CementParkell, Inc
K201937Ceramir Restore QuikCapDoxa Dental AB
K201856Provicol QM AestheticVOCO GmbH
K201790Dual Cure Resin CementRizhao HuGe Biomaterials Company, Ltd.
K200798G-CEM ONEGC America Inc.
K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)Prevest Denpro Limited
K193484GC Fuji Triage EPGC America Inc.
K193260U-Cem Premium & MAZIC CemVericom Co., Ltd.
K192992Suglue 33M Deutschland GMBH
K192530Surefil One Self-adhesive Composite HybridDentsply Sirona

Global Unique Device Identification Database

00366975002594Cement, Dental
00366975001139Cement, Dental
00366975001122Cement, Dental
10304040040437CEMENT, DENTAL
10304040040420CEMENT, DENTAL
10304040040413CEMENT, DENTAL
00304040006948CEMENT, DENTAL
00304040006917CEMENT, DENTAL
00304040005514CEMENT, DENTAL
00304040005507CEMENT, DENTAL
00304040005491CEMENT, DENTAL
00304040005392CEMENT, DENTAL
00304040005118CEMENT, DENTAL
00304040004173CEMENT, DENTAL
00304040004166CEMENT, DENTAL

Maude Adverse Events

CEMENTUNK2020-02-11
INTEGRITY TEMPGRIPDENTSPLY CAULK2020-01-06
3M RELYX3M ESPE DENTAL PRODUCTS2019-06-24
CALIBRA CERAMDENTSPLY CAULK2019-06-01
CALIBRA CERAMDENTSPLY CAULK2019-06-01
CALIBRA CERAMDENTSPLY CAULK2019-06-01
CALIBRA CERAMDENTSPLY CAULK2019-06-01
CALIBRA CERAMDENTSPLY CAULK2019-06-01
CALIBRA CERAMDENTSPLY CAULK2019-06-01
MERON APPLICATION CAPSULEVOCO GMBH2019-02-22
MERON APPLICATION CAPSULEVOCO GMBH2019-02-12
WALGREENS LOST FILLING AND LOOSE CAP REPAIR2019-01-29
GLASS IONOMER LUTING CEMENTGC CORPORATION -FUJI OYAMA FACTORY2019-01-11
IRM CAPS ENCAPSULATED ZOE INTERNEDIATE RESTORATIVE MATERIALDENTSPLY CAULK2019-01-10
MAXCEM ELITEKERR CORPORATION2018-08-22
CEMENT USED FOR DENTAL IMPLANTUNK2018-08-10
IRM CEMENTDENTSPLY DETREY GMBH2018-07-03
SPEEDCEM PLUSIVOCLAR VIVADENT AG2018-04-13
RELYX LUTING PLUS AUTOMIX CEMENT3M ESPE DENTAL PRODUCTS2017-09-29
3M ESPE RELYX LUTING PLUS CEMENT3M ESPE DENTAL PRODUCTS2017-08-10
3M ESPE KETAC UNIVERSAL APLICAP3M DEUTSCHLAND GMBH2017-06-28
FYNAL PERMANENT ZOE CEMENTDENTSPLY CAULK2017-06-21
FYNAL PERMANENT ZOE CEMENTDENTSPLY CAULK2017-06-21
IRM CAPS ENCAPSULATED ZOE INTERNEDIATE RESTORATIVE MATERIALDENTSPLY CAULK2017-06-16
3M ESPE RELYX ULTIMATE CEMENT3M DEUTSCHLAND GMBH2017-05-10
RELYX LUTING PLUS CEMENT3M ESPE DENTAL PRODUCTS2017-04-27
RELYX LUTING LUTING CEMENT3M ESPE DENTAL PRODUCTS2017-03-14
VITREBOND3M2017-02-22
RELYX LUTING LUTING CEMENT3M ESPE DENTAL PRODUCTS2017-02-21
RELYX LUTING LUTING CEMENT3M ESPE DENTAL PRODUCTS2017-01-04
RELYX LUTING LUTING CEMENT3M ESPE DENTAL PRODUCTS2017-01-04
RELYX LUTING LUTING CEMENT3M ESPE DENTAL PRODUCTS2016-12-27
3M ESPE KETAC CEM EASYMIX3M DEUTSCHLAND GMBH2016-12-21
3M ESPE RELYX ULTIMATE3M DEUTSCHLAND GMBH2016-12-21
FUJI II LC COREGC CORPORATION2016-12-07
KALSOGEN PLUSDENTSPLY DETREY GMBH2016-11-11
TELIO CS LINKIVOCLAR VIVADENT AG2016-10-05
RELYX ULTIMATE ADHESIVE RESIN CEMENT3M DEUTSCHLAND GMBH2016-08-16
RELYX LUTING PLUS CEMENT3M ESPE DENTAL PRODUCTS2016-07-14
RELYX U200 CEMENT3M DEUTSCHLAND GMBH2016-06-09
KETAC CEM PLUS AUTOMIX3M ESPE DENTAL PRODUCTS2016-06-08
RELYX LUTING PLUS AUTOMIX CEMENT3M ESPE DENTAL PRODUCTS2016-06-01
ALADDIN FLOWDENTSPLY CAULK2016-05-13
3M ESPE RELYX UNICEM 2 AUTOMIX3M DEUTSCHLAND GMBH2016-05-04
3M ESPE RELYX UNICEM 2 AUTOMIX3M DEUTSCHLAND GMBH2016-04-13
RELYX LUTING PLUS AUTOMIX CEMENT3M ESPE DENTAL PRODUCTS2016-03-08
RELYX ULTIMATE ADHESIVE RESIN CEMENT3M DEUTSCHLAND GMBH2016-01-07
RELYX ULTIMATE ADHESIVE RESIN CEMENT3M DEUTSCHLAND GMBH2015-12-21
RELYX LUTING LUTING CEMENT3M ESPE DENTAL PRODUCTS2015-12-21
RELYX UNICEM 2 CEMENT3M DEUTSCHLAND GMBH2015-12-10
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