FDA Product Code
FDA Product Code EMA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3275
510(k) Clearances — 509 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262983 | EsTemp Implant | Spident Co., Ltd. | 2026-09-25 | Special | PDF ↗ |
| K254201 | Any-Cem | Mediclus Co., Ltd. | 2026-08-13 | Traditional | PDF ↗ |
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 | Traditional | PDF ↗ |
| K261166 | DIA-CEM | DiaDent Group International | 2026-07-09 | Traditional | PDF ↗ |
| K254109 | G-CEM UNIVERSAL | GC America, Inc. | 2026-05-18 | Traditional | PDF ↗ |
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | 2026-04-15 | Traditional | PDF ↗ |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | 2026-03-20 | Traditional | PDF ↗ |
| K254063 | iCEM Universal Plus | Kulzer, LLC | 2025-12-19 | Abbreviated | PDF ↗ |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 | Traditional | PDF ↗ |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | 2025-12-09 | Traditional | PDF ↗ |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | 2025-10-28 | Traditional | PDF ↗ |
| K250953 | EQUIA LC ONE | GC America, Inc. | 2025-09-19 | Traditional | PDF ↗ |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | 2025-09-02 | Traditional | PDF ↗ |
| K251470 | ResiCem EX | Shofu Dental Corporation | 2025-07-11 | Traditional | PDF ↗ |
| K250156 | Choice 2 DC | Bisco, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K250566 | EsCem RMGI | Spident Co., Ltd. | 2025-06-20 | Traditional | PDF ↗ |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. | 2025-01-10 | Traditional | PDF ↗ |
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | 2024-07-24 | Traditional | PDF ↗ |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024-06-28 | Traditional | PDF ↗ |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 2024-04-02 | Special | PDF ↗ |
| K233161 | BeautiLink SA | Shofu Dental Corporation | 2023-09-28 | Traditional | PDF ↗ |
| K231552 | Dia-Cem | DiaDent Group International | 2023-07-28 | Traditional | PDF ↗ |
| K214076 | EsCem | Spident Co., Ltd. | 2022-12-19 | Traditional | PDF ↗ |
| K222253 | GlasIonomer FX ULTRA | Shofu Dental Corporation | 2022-09-22 | Traditional | PDF ↗ |
| K214118 | Riva Cem Automix | Sdi Limited | 2022-08-30 | Traditional | PDF ↗ |
| K220640 | Bifix Hybrid Abutment Cement | Voco GmbH | 2022-08-23 | Traditional | PDF ↗ |
| K213609 | NOVA RESIN dual cure, self adhesive resin cement | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022-08-09 | Traditional | PDF ↗ |
| K213201 | DeltaFil, DeltaFil Conditioner | DMG Chemisch-Pharmazeutische Fabrik GmbH | 2022-06-01 | Traditional | PDF ↗ |
| K210259 | Parkell Self-Adhesive Cement | Parkell, Inc. | 2022-01-20 | Traditional | PDF ↗ |
| K210473 | Nova 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 | 2021-11-02 | Traditional | PDF ↗ |
| K211237 | UltraTemp Rez II | Ultradent Products, Inc. | 2021-07-13 | Traditional | PDF ↗ |
| K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021-06-11 | Traditional | PDF ↗ |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | Prevest Denpro Limited | 2021-05-13 | Traditional | PDF ↗ |
| K200798 | G-CEM ONE | GC America, Inc. | 2020-11-24 | Traditional | PDF ↗ |
| K201937 | Ceramir Restore QuikCap | Doxa Dental AB | 2020-11-13 | Abbreviated | PDF ↗ |
| K201790 | Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2020-09-29 | Traditional | PDF ↗ |
| K201856 | Provicol QM Aesthetic | Voco GmbH | 2020-08-26 | Special | PDF ↗ |
| K193260 | U-Cem Premium & MAZIC Cem | Vericom Co., Ltd. | 2020-08-21 | Traditional | PDF ↗ |
| K193484 | GC Fuji Triage EP | GC America, Inc. | 2020-07-02 | Traditional | PDF ↗ |
| K192007 | TheraBase, TheraBase Ca | Bisco, Inc. | 2020-03-17 | Traditional | PDF ↗ |
| K192530 | Surefil one Self-adhesive Composite Hybrid | Dentsply Sirona | 2020-01-23 | Traditional | PDF ↗ |
| K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co. KG | 2019-11-08 | Traditional | PDF ↗ |
| K192992 | Suglue 3 | 3M Deutschland GmbH | 2019-11-05 | Traditional | PDF ↗ |
| K183465 | Allcem, Allcem Core | Dentscare Ltda | 2019-11-02 | Traditional | PDF ↗ |
| K191548 | Nexus Universal Self-Cure | Kerr Corporation | 2019-10-11 | Traditional | PDF ↗ |
| K182854 | GC FujiCEM 2 (Improved) | GC America, Inc. | 2019-07-11 | Traditional | PDF ↗ |
| K191122 | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | 3M Espe Dental Products | 2019-05-29 | Traditional | PDF ↗ |
| K183537 | PANAVIA SA Cement Universal | Kuraray Noritake Dental, Inc. | 2019-04-25 | Traditional | PDF ↗ |
| K171449 | Metacem | Meta Biomed Co., Ltd. | 2018-05-15 | Traditional | PDF ↗ |
| K180386 | Meron Plus QM | Voco GmbH | 2018-05-08 | Traditional | PDF ↗ |
| K172382 | GC Fuji Direct | GC America, Inc. | 2018-04-02 | Traditional | PDF ↗ |
| K162960 | TotalC-Ram | Itena Clinical | 2017-03-14 | Abbreviated | PDF ↗ |
| K160345 | Glass Ionomer Cement | Shandong Huge Dental Material Corporation | 2017-03-03 | Traditional | PDF ↗ |
| K170330 | 3M Protemp Cement Temporary Dental Cement | 3M Company | 2017-02-06 | Traditional | PDF ↗ |
| K160800 | DuoCem | Coltene/Whaledent AG | 2016-11-16 | Traditional | PDF ↗ |
| K161851 | Glass Ionomer Cement (Luting) | Shandong Huge Dental Material Corporation | 2016-10-31 | Traditional | PDF ↗ |
| K160443 | TempoCem Clear | Dmg USA, Inc. | 2016-09-30 | Traditional | PDF ↗ |
| K160774 | IonoStar Plus | Voco GmbH | 2016-08-03 | Traditional | PDF ↗ |
| K161256 | TheraCem | Bisco, Inc. | 2016-07-29 | Traditional | PDF ↗ |
| K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America, Inc. | 2016-07-06 | Traditional | PDF ↗ |
| K142130 | ORAL BOND | Steiner Laboratories | 2016-06-06 | Traditional | PDF ↗ |
| K153174 | Ketac Universal Aplicap | 3M Deutschland GmbH | 2016-04-13 | Traditional | PDF ↗ |
| K152652 | PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement | Gaia Dental Products, Inc. | 2016-04-05 | Traditional | PDF ↗ |
| K152691 | EDS Universal Cement | Essential Dental Systems, Inc. | 2016-02-25 | Traditional | PDF ↗ |
| K151526 | Zone, ZoneFree, Zone A1 | Sybron Dental Specialties | 2015-09-10 | Traditional | PDF ↗ |
| K150704 | 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 | Kuraray Noritake Dental, Inc. | 2015-08-21 | Traditional | PDF ↗ |
| K151332 | Nexus Universal, Nexus Universal Chroma | Sybron Dental Specialties | 2015-08-17 | Abbreviated | PDF ↗ |
| K150601 | Zeramic Adhesive Resin Cement | Premier Dental Company Products | 2015-07-22 | Traditional | PDF ↗ |
| K150727 | ESTECEM | Tokuyama Dental Corporation | 2015-06-17 | Traditional | PDF ↗ |
| K142446 | Fixtemp Cement | Exacta Dental Direct, Inc. | 2015-06-04 | Traditional | PDF ↗ |
| K143212 | Bifix Temp | Voco GmbH | 2015-05-01 | Traditional | PDF ↗ |
| K142623 | PANAVIA SA Cement Plus Handmix | Kuraray Noritake Dental, Inc. | 2015-02-26 | Traditional | PDF ↗ |
| K142625 | 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) | Kuraray Noritake Dental, Inc. | 2015-01-27 | Traditional | PDF ↗ |
| K141503 | DENALI 501CEMENT | Denali Corporation | 2014-11-10 | Traditional | PDF ↗ |
| K140993 | IONOSTAR MOLAR | Voco GmbH | 2014-10-20 | Traditional | PDF ↗ |
| K134021 | ESTEMP IMPLANT, ESTEMP CLEAR | Spident Co., Ltd. | 2014-06-10 | Traditional | PDF ↗ |
| K132393 | CERCOM II CEMENT | Denali Corporation | 2014-03-14 | Traditional | PDF ↗ |
| K132255 | ULTRACEM | Ultradent Products Inc. / Oratech, LLC | 2013-10-24 | Traditional | PDF ↗ |
| K130436 | MULTILINK HYBRID ABUTMENT CEMENT | Ivoclar Vivadent, AG | 2013-08-20 | Traditional | PDF ↗ |
| K130421 | MERON APPLICATION CAPSULES | Voco GmbH | 2013-08-14 | Traditional | PDF ↗ |
| K122551 | PROVITEMP | Itena Clinical | 2013-06-14 | Abbreviated | PDF ↗ |
| K122974 | TRYOUT-VPS HOLDING PASTE | Crown Delta Corp. | 2013-05-17 | Traditional | PDF ↗ |
| K122549 | DENTO TEMP | Itena Clinical | 2013-04-26 | Abbreviated | PDF ↗ |
| K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | Itena Clinical | 2013-04-19 | Abbreviated | PDF ↗ |
| K130223 | RMGI FILL | Pulpdent Corporation | 2013-03-29 | Traditional | PDF ↗ |
| K123824 | VITRO FIL LC | Dfl Industria E Comercio SA | 2013-02-21 | Traditional | PDF ↗ |
| K123595 | NEXUS RMGI | Kerr Corporation | 2013-02-19 | Traditional | PDF ↗ |
| K123826 | VITRO MOLAR | Dfl Industria E Comercio SA | 2013-02-14 | Traditional | PDF ↗ |
| K121621 | SOLOCEM | Coltene/Whaledent AG | 2013-01-08 | Traditional | PDF ↗ |
| K123265 | RMGI LOW VISCOSITY | Pulpdent Corporation | 2012-12-07 | Traditional | PDF ↗ |
| K123273 | HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) | Temrex Corp. | 2012-12-07 | Traditional | PDF ↗ |
| K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | Novocol, Inc. | 2012-07-31 | Abbreviated | PDF ↗ |
| K120243 | GAM-200 | GC America, Inc. | 2012-06-27 | Traditional | PDF ↗ |
| K120159 | BEAUTICEM SA | Shofu Dental Corporation | 2012-06-18 | Traditional | PDF ↗ |
| K120432 | TELIO CS CEM IMPLANT | Ivoclar Vivadent, AG | 2012-06-08 | Traditional | PDF ↗ |
| K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | Kuraray Medical, Inc. | 2012-03-30 | Traditional | PDF ↗ |
| K120378 | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S | Kuraray Medical, Inc. | 2012-03-30 | Traditional | PDF ↗ |
| K112307 | RESIGLASS PASTE | Shofu Dental Corporation | 2012-03-28 | Traditional | PDF ↗ |
| K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | Prime Dental Manufacturing, Inc. | 2012-01-23 | Traditional | PDF ↗ |
| K113040 | CERAMIR CROWN & BRIDGE | Doxa Dental AB | 2011-12-28 | Abbreviated | PDF ↗ |
Product code EMA · Class II · Dental. Data: openFDA.