ClearanceBrief
Panels › Dental › Product code EMA · Class 2

Cement, Dental

Regulation 872.3275

10510(k)s in 12 months (509 all time)
0recalls in 12 months (16 all time)
13recalls that name a 510(k)
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Top companies in EMA

Company510(k)sRecalls
GC America, Inc.300
Voco GmbH262
Shofu Dental Corp.240
Dentsply Intl.190
Pulpdent Corp.140
Sybron Dental Specialties140
3M Company120
Bisco, Inc.92
Espe GmbH (Us)100
Coltene/Whaledent AG90
Decided510(k)Device and applicantCode
Sep 25, 2026K262983EsTemp Implant
Spident Co., Ltd., KR
EMA
Aug 13, 2026K254201Any-Cem
Mediclus Co., Ltd., KR
EMA
Aug 7, 2026K261937PacTemp Automix NE
The Belport Company Inc., DBA Gingi-Pak
EMA
Jul 9, 2026K261166DIA-CEM
DiaDent Group International, KR
EMA
May 18, 2026K254109G-CEM UNIVERSAL
GC America, Inc.
EMA
Apr 15, 2026K253337REGEN Bioactive Cement
Inter-Med, Inc.
EMA
Mar 20, 2026K252606Bifix Veneer LC, Bifix Veneer Try-In
Voco GmbH, DE
EMA
Dec 19, 2025K254063iCEM Universal Plus
Kulzer, LLC
EMA
Dec 12, 2025K252785TopCEM Vigor SA Self-Adhesive Resin Cement
Rizhao Huge Biomaterials Company, Ltd., CN
EMA
Dec 9, 2025K252808GlasIonomer FX-LC
Shofu Dental Corporation
EMA
Oct 28, 2025K252165ZIRCONOMER P
Shofu Dental Corporation
EMA
Sep 19, 2025K250953EQUIA LC ONE
GC America, Inc.
EMA
Sep 2, 2025K251775RODIN Cement
Belport Company, Inc., Gingi-Pak
EMA
Jul 11, 2025K251470ResiCem EX
Shofu Dental Corporation
EMA
Jul 11, 2025K250156Choice 2 DC
Bisco, Inc.
EMA
Jun 20, 2025K250566EsCem RMGI
Spident Co., Ltd., KR
EMA
Jan 10, 2025K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
Overfibers S.R.L., IT
EMA
Jul 24, 2024K240714Insure® Universal; Insure® Universal Automix
Cosmedent, Inc.
EMA
Jun 28, 2024K241204TopCEM-Veneer Light Cure Veneer Cement
Rizhao Huge Biomaterials Company, Ltd., CN
EMA
Apr 2, 2024K240888Calibra Abutment Resin Cement
Dentsply Sirona
EMA
Sep 28, 2023K233161BeautiLink SA
Shofu Dental Corporation
EMA
Jul 28, 2023K231552Dia-Cem
DiaDent Group International, KR
EMA
Dec 19, 2022K214076EsCem
Spident Co., Ltd., KR
EMA
Sep 22, 2022K222253GlasIonomer FX ULTRA
Shofu Dental Corporation
EMA
Aug 30, 2022K214118Riva Cem Automix
Sdi Limited, AU
EMA
Aug 23, 2022K220640Bifix Hybrid Abutment Cement
Voco GmbH, DE
EMA
Aug 9, 2022K213609NOVA RESIN dual cure, self adhesive resin cement
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS, TR
EMA
Jun 1, 2022K213201DeltaFil, DeltaFil Conditioner
DMG Chemisch-Pharmazeutische Fabrik GmbH, DE
EMA
Jan 20, 2022K210259Parkell Self-Adhesive Cement
Parkell, Inc.
EMA
Nov 2, 2021K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS, TR
EMA
Jul 13, 2021K211237UltraTemp Rez II
Ultradent Products, Inc.
EMA
Jun 11, 2021K210504PANAVIA Veneer LC
Kuraray Noritake Dental, Inc., JP
EMA
May 13, 2021K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin
Prevest Denpro Limited, IN
EMA
Nov 24, 2020K200798G-CEM ONE
GC America, Inc.
EMA
Nov 13, 2020K201937Ceramir Restore QuikCap
Doxa Dental AB, SE
EMA
Sep 29, 2020K201790Dual Cure Resin Cement
Rizhao Huge Biomaterials Company, Ltd., CN
EMA
Aug 26, 2020K201856Provicol QM Aesthetic
Voco GmbH, DE
EMA
Aug 21, 2020K193260U-Cem Premium & MAZIC Cem
Vericom Co., Ltd., KR
EMA
Jul 2, 2020K193484GC Fuji Triage EP
GC America, Inc.
EMA
Mar 17, 2020K192007TheraBase, TheraBase Ca
Bisco, Inc.
EMA
Jan 23, 2020K192530Surefil one Self-adhesive Composite Hybrid
Dentsply Sirona
EMA
Nov 8, 2019K191527Visalys CemCore, Visalys Cem Core Try In Paste
Kettenbach GmbH & Co. KG, DE
EMA
Nov 5, 2019K192992Suglue 3
3M Deutschland GmbH, DE
EMA
Nov 2, 2019K183465Allcem, Allcem Core
Dentscare Ltda, BR
EMA
Oct 11, 2019K191548Nexus Universal Self-Cure
Kerr Corporation
EMA
Jul 11, 2019K182854GC FujiCEM 2 (Improved)
GC America, Inc.
EMA
May 29, 2019K1911223M RelyX Pediatric Resin Modified Glass Ionomer Cement
3M Espe Dental Products
EMA
Apr 25, 2019K183537PANAVIA SA Cement Universal
Kuraray Noritake Dental, Inc., JP
EMA
May 15, 2018K171449Metacem
Meta Biomed Co., Ltd., KR
EMA
May 8, 2018K180386Meron Plus QM
Voco GmbH, DE
EMA

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