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EMA

Cement, Dental

Product code
EMA
Device name
Cement, Dental
Device class
Class 2
21 CFR
21 CFR 872.3275
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
508

510(k) clearances, last 3 years (20)

Last three years. Most recent: 2026-08-13.

NumberDecision dateApplicantDevice name
K2542012026-08-13Mediclus Co., Ltd.Any-Cem summary
K2619372026-08-07The Belport Company Inc., DBA Gingi-PaPacTemp Automix NE summary
K2611662026-07-09DiaDent Group InternationalDIA-CEM summary
K2541092026-05-18GC America, Inc.G-CEM UNIVERSAL summary
K2533372026-04-15Inter-Med, Inc.REGEN Bioactive Cement summary
K2526062026-03-20Voco GmbHBifix Veneer LC, Bifix Veneer Try-In
K2540632025-12-19Kulzer, LLCiCEM Universal Plus summary
K2527852025-12-12Rizhao Huge Biomaterials Company, Ltd.TopCEM Vigor SA Self-Adhesive Resin Cement summary
K2528082025-12-09Shofu Dental CorporationGlasIonomer FX-LC
K2521652025-10-28Shofu Dental CorporationZIRCONOMER P
K2509532025-09-19GC America, Inc.EQUIA LC ONE summary
K2517752025-09-02Belport Company, Inc., Gingi-PakRODIN Cement
K2514702025-07-11Shofu Dental CorporationResiCem EX
K2501562025-07-11Bisco, Inc.Choice 2 DC summary
K2505662025-06-20Spident Co., Ltd.EsCem RMGI summary
K2423662025-01-10Overfibers S.R.L.OverCEM SA Universal; OverCEM SA Translucent; OverCE summary
K2407142024-07-24Cosmedent, Inc.Insure® Universal; Insure® Universal Automix
K2412042024-06-28Rizhao Huge Biomaterials Company, Ltd.TopCEM-Veneer Light Cure Veneer Cement summary
K2408882024-04-02Dentsply SironaCalibra Abutment Resin Cement summary
K2331612023-09-28Shofu Dental CorporationBeautiLink SA
Official FDA classification page: EMA
Classification and pathway per current FDA publications. Data from openFDA (CC0).