Cement, Dental
FDA product code EMA · 496 cleared devices
Class 2
Dental
- Regulation
- 21 CFR 872.3275
- Review panel
- DE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-07-26 – 2026-09-25
EMA
2026-09-25
EMA
2026-08-13
Any-Cem
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EMA
2026-08-07
PacTemp Automix NE
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EMA
2026-07-09
DIA-CEM
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EMA
2026-05-18
G-CEM UNIVERSAL
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EMA
2026-04-15
REGEN Bioactive Cement
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EMA
2026-03-20
Bifix Veneer LC, Bifix Veneer Try-In
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EMA
2025-12-19
iCEM Universal Plus
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EMA
2025-12-12
TopCEM Vigor SA Self-Adhesive Resin Cement
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EMA
2025-12-09
GlasIonomer FX-LC
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EMA
2025-10-28
ZIRCONOMER P
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EMA
2025-09-19
EQUIA LC ONE
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EMA
2025-09-02
RODIN Cement
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EMA
2025-07-11
ResiCem EX
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EMA
2025-07-11
Choice 2 DC
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EMA
2025-06-20
EsCem RMGI
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EMA
2025-01-10
OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
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EMA
2024-07-24
Insure® Universal; Insure® Universal Automix
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EMA
2024-06-28
TopCEM-Veneer Light Cure Veneer Cement
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EMA
2024-04-02
Calibra Abutment Resin Cement
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EMA
2023-09-28
BeautiLink SA
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EMA
2023-07-28
Dia-Cem
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EMA
2022-12-19
EsCem
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EMA
2022-09-22
GlasIonomer FX ULTRA
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EMA
2022-08-30
Riva Cem Automix
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EMA
2022-08-23
Bifix Hybrid Abutment Cement
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EMA
2022-08-09
NOVA RESIN dual cure, self adhesive resin cement
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EMA
2022-06-01
DeltaFil, DeltaFil Conditioner
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EMA
2022-01-20
Parkell Self-Adhesive Cement
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EMA
2021-11-02
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
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EMA
2021-07-13
UltraTemp Rez II
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EMA
2021-06-11
PANAVIA Veneer LC
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EMA
2021-05-13
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)
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EMA
2020-11-24
G-CEM ONE
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EMA
2020-11-13
Ceramir Restore QuikCap
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EMA
2020-09-29
Dual Cure Resin Cement
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EMA
2020-08-26
Provicol QM Aesthetic
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EMA
2020-08-21
U-Cem Premium & MAZIC Cem
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EMA
2020-07-02
GC Fuji Triage EP
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EMA
2020-03-17
TheraBase, TheraBase Ca
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EMA
2020-01-23
Surefil one Self-adhesive Composite Hybrid
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EMA
2019-11-08
Visalys CemCore, Visalys Cem Core Try In Paste
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EMA
2019-11-05
Suglue 3
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EMA
2019-11-02
Allcem, Allcem Core
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EMA
2019-10-11
Nexus Universal Self-Cure
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EMA
2019-07-11
GC FujiCEM 2 (Improved)
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EMA
2019-05-29
3M RelyX Pediatric Resin Modified Glass Ionomer Cement
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EMA
2019-04-25
PANAVIA SA Cement Universal
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EMA
2018-05-15
Metacem
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EMA
2018-05-08
Meron Plus QM
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EMA
2018-04-02
GC Fuji Direct
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EMA
2017-03-14
TotalC-Ram
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EMA
2017-03-03
Glass Ionomer Cement
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EMA
2017-02-06
3M Protemp Cement Temporary Dental Cement
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EMA
2016-11-16
DuoCem
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EMA
2016-10-31
Glass Ionomer Cement (Luting)
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EMA
2016-09-30
TempoCem Clear
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EMA
2016-08-03
IonoStar Plus
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EMA
2016-07-29
TheraCem
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EMA
2016-07-06
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
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EMA
2016-06-06
ORAL BOND
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EMA
2016-04-13
Ketac Universal Aplicap
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EMA
2016-04-05
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
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EMA
2016-02-25
EDS Universal Cement
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EMA
2013-10-24
ULTRACEM
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EMA
2013-08-20
MULTILINK HYBRID ABUTMENT CEMENT
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EMA
2013-08-14
MERON APPLICATION CAPSULES
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EMA
2013-06-14
PROVITEMP
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EMA
2013-05-17
TRYOUT-VPS HOLDING PASTE
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EMA
2013-04-26
DENTO TEMP
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EMA
2013-04-19
PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM
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EMA
2013-03-29
RMGI FILL
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EMA
2013-02-21
VITRO FIL LC
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EMA
2013-02-19
NEXUS RMGI
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EMA
2013-02-14
VITRO MOLAR
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EMA
2013-01-08
SOLOCEM
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EMA
2012-12-07
HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
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EMA
2012-12-07
RMGI LOW VISCOSITY
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EMA
2012-07-31
DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
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EMA
2012-06-27
GAM-200
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EMA
2012-06-18
BEAUTICEM SA
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EMA
2012-06-08
TELIO CS CEM IMPLANT
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EMA
2012-03-30
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
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EMA
2012-03-30
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S
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EMA
2012-03-28
RESIGLASS PASTE
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EMA
2012-01-23
PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
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EMA
2011-12-28
CERAMIR CROWN & BRIDGE
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EMA
2011-11-17
HY-BOND RESIGLASS
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EMA
2011-09-16
PERMASHADE VENEER CEMENT
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EMA
2011-09-02
IP TEMP CEMENT
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EMA
2011-06-06
CLEARTEMP
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EMA
2011-06-03
SUGLUE-10
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EMA
2011-05-05
RELYX LUTING PLUS AUTOMIX
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EMA
2011-03-04
BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
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EMA
2010-11-19
VOCO IONOFIL MOLAR AC QUICK
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EMA
2010-10-29
TI-CORE FLOW
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EMA
2010-10-08
DUOLINK II
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EMA
2010-09-29
PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
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EMA
2010-09-17
GC FUJI TEMP
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EMA
2010-08-19
ADVANCED GLASS IONOMER (K-130) RESTORATIVE
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