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EMA

507 FDA 510(k) clearances · Product code

75 daysmedian time to decision
209 days90th percentile
507clearances measured

FDA profile

Official device name
Cement, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3275
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2013: 385 · 2014: 207 · 2015: 85 · 2016: 16 · 2017: 13 · 2019: 12
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
PacTemp Automix NE (K261937)The Belport Company Inc., DBA Gingi-Pak2026-08-07
DIA-CEM (K261166)DiaDent Group International2026-07-09
G-CEM UNIVERSAL (K254109)GC America, Inc.2026-05-18
REGEN Bioactive Cement (K253337)Inter-Med, Inc.2026-04-15
Bifix Veneer LC, Bifix Veneer Try-In (K252606)Voco GmbH2026-03-20
iCEM Universal Plus (K254063)Kulzer, LLC2025-12-19
TopCEM Vigor SA Self-Adhesive Resin Cement (K252785)Rizhao Huge Biomaterials Company, Ltd.2025-12-12
GlasIonomer FX-LC (K252808)Shofu Dental Corporation2025-12-09
ZIRCONOMER P (K252165)Shofu Dental Corporation2025-10-28
EQUIA LC ONE (K250953)GC America, Inc.2025-09-19
RODIN Cement (K251775)Belport Company, Inc., Gingi-Pak2025-09-02
Choice 2 DC (K250156)Bisco, Inc.2025-07-11
ResiCem EX (K251470)Shofu Dental Corporation2025-07-11
EsCem RMGI (K250566)Spident Co., Ltd.2025-06-20
OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment (K242366)Overfibers S.R.L.2025-01-10
Insure® Universal; Insure® Universal Automix (K240714)Cosmedent, Inc.2024-07-24
TopCEM-Veneer Light Cure Veneer Cement (K241204)Rizhao Huge Biomaterials Company, Ltd.2024-06-28
Calibra Abutment Resin Cement (K240888)Dentsply Sirona2024-04-02
BeautiLink SA (K233161)Shofu Dental Corporation2023-09-28
Dia-Cem (K231552)DiaDent Group International2023-07-28
EsCem (K214076)Spident Co., Ltd.2022-12-19
GlasIonomer FX ULTRA (K222253)Shofu Dental Corporation2022-09-22
Riva Cem Automix (K214118)Sdi Limited2022-08-30
Bifix Hybrid Abutment Cement (K220640)Voco GmbH2022-08-23
NOVA RESIN dual cure, self adhesive resin cement (K213609)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2022-08-09
DeltaFil, DeltaFil Conditioner (K213201)DMG Chemisch-Pharmazeutische Fabrik GmbH2022-06-01
Parkell Self-Adhesive Cement (K210259)Parkell, Inc.2022-01-20
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) (K210473)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2021-11-02
UltraTemp Rez II (K211237)Ultradent Products, Inc.2021-07-13
PANAVIA Veneer LC (K210504)Kuraray Noritake Dental, Inc.2021-06-11
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) (K200555)Prevest Denpro Limited2021-05-13
G-CEM ONE (K200798)GC America, Inc.2020-11-24
Ceramir Restore QuikCap (K201937)Doxa Dental AB2020-11-13
Dual Cure Resin Cement (K201790)Rizhao Huge Biomaterials Company, Ltd.2020-09-29
Provicol QM Aesthetic (K201856)Voco GmbH2020-08-26
U-Cem Premium & MAZIC Cem (K193260)Vericom Co., Ltd.2020-08-21
GC Fuji Triage EP (K193484)GC America, Inc.2020-07-02
TheraBase, TheraBase Ca (K192007)Bisco, Inc.2020-03-17
Surefil one Self-adhesive Composite Hybrid (K192530)Dentsply Sirona2020-01-23
Visalys CemCore, Visalys Cem Core Try In Paste (K191527)Kettenbach GmbH & Co. KG2019-11-08
Suglue 3 (K192992)3M Deutschland GmbH2019-11-05
Allcem, Allcem Core (K183465)Dentscare Ltda2019-11-02
Nexus Universal Self-Cure (K191548)Kerr Corporation2019-10-11
GC FujiCEM 2 (Improved) (K182854)GC America, Inc.2019-07-11
3M RelyX Pediatric Resin Modified Glass Ionomer Cement (K191122)3M Espe Dental Products2019-05-29
PANAVIA SA Cement Universal (K183537)Kuraray Noritake Dental, Inc.2019-04-25
Metacem (K171449)Meta Biomed Co., Ltd.2018-05-15
Meron Plus QM (K180386)Voco GmbH2018-05-08
GC Fuji Direct (K172382)GC America, Inc.2018-04-02
TotalC-Ram (K162960)Itena Clinical2017-03-14
Glass Ionomer Cement (K160345)Shandong Huge Dental Material Corporation2017-03-03
3M Protemp Cement Temporary Dental Cement (K170330)3M Company2017-02-06
DuoCem (K160800)Coltene/Whaledent AG2016-11-16
Glass Ionomer Cement (Luting) (K161851)Shandong Huge Dental Material Corporation2016-10-31
TempoCem Clear (K160443)Dmg USA, Inc.2016-09-30
IonoStar Plus (K160774)Voco GmbH2016-08-03
TheraCem (K161256)Bisco, Inc.2016-07-29
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (K153231)GC America, Inc.2016-07-06
ORAL BOND (K142130)Steiner Laboratories2016-06-06
Ketac Universal Aplicap (K153174)3M Deutschland GmbH2016-04-13
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement (K152652)Gaia Dental Products, Inc.2016-04-05
EDS Universal Cement (K152691)Essential Dental Systems, Inc.2016-02-25
Zone, ZoneFree, Zone A1 (K151526)Sybron Dental Specialties2015-09-10
PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer (K150704)Kuraray Noritake Dental, Inc.2015-08-21
Nexus Universal, Nexus Universal Chroma (K151332)Sybron Dental Specialties2015-08-17
Zeramic Adhesive Resin Cement (K150601)Premier Dental Company Products2015-07-22
ESTECEM (K150727)Tokuyama Dental Corporation2015-06-17
Fixtemp Cement (K142446)Exacta Dental Direct, Inc.2015-06-04
Bifix Temp (K143212)Voco GmbH2015-05-01
PANAVIA SA Cement Plus Handmix (K142623)Kuraray Noritake Dental, Inc.2015-02-26
PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) (K142625)Kuraray Noritake Dental, Inc.2015-01-27
DENALI 501CEMENT (K141503)Denali Corporation2014-11-10
IONOSTAR MOLAR (K140993)Voco GmbH2014-10-20
ESTEMP IMPLANT, ESTEMP CLEAR (K134021)Spident Co., Ltd.2014-06-10
CERCOM II CEMENT (K132393)Denali Corporation2014-03-14
ULTRACEM (K132255)Ultradent Products Inc. / Oratech, LLC2013-10-24
MULTILINK HYBRID ABUTMENT CEMENT (K130436)Ivoclar Vivadent, AG2013-08-20
MERON APPLICATION CAPSULES (K130421)Voco GmbH2013-08-14
PROVITEMP (K122551)Itena Clinical2013-06-14
TRYOUT-VPS HOLDING PASTE (K122974)Crown Delta Corp.2013-05-17
DENTO TEMP (K122549)Itena Clinical2013-04-26
PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM (K121804)Itena Clinical2013-04-19
RMGI FILL (K130223)Pulpdent Corporation2013-03-29
VITRO FIL LC (K123824)Dfl Industria E Comercio SA2013-02-21
NEXUS RMGI (K123595)Kerr Corporation2013-02-19
VITRO MOLAR (K123826)Dfl Industria E Comercio SA2013-02-14
SOLOCEM (K121621)Coltene/Whaledent AG2013-01-08
HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) (K123273)Temrex Corp.2012-12-07
RMGI LOW VISCOSITY (K123265)Pulpdent Corporation2012-12-07
DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT (K120283)Novocol, Inc.2012-07-31
GAM-200 (K120243)GC America, Inc.2012-06-27
BEAUTICEM SA (K120159)Shofu Dental Corporation2012-06-18
TELIO CS CEM IMPLANT (K120432)Ivoclar Vivadent, AG2012-06-08
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S (K120379)Kuraray Medical, Inc.2012-03-30
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S (K120378)Kuraray Medical, Inc.2012-03-30
RESIGLASS PASTE (K112307)Shofu Dental Corporation2012-03-28
PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT (K112574)Prime Dental Manufacturing, Inc.2012-01-23
CERAMIR CROWN & BRIDGE (K113040)Doxa Dental AB2011-12-28
HY-BOND RESIGLASS (K111855)Shofu Dental Corp.2011-11-17
PERMASHADE VENEER CEMENT (K111836)Ultradent Products, Inc.2011-09-16
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