Home › Device types › EJK
Liner, Cavity, Calcium Hydroxide
FDA product code EJK · Class 2 · Dental
225
Registered devices
14
Adverse events
1
Recalls
78
510(k) clearances
Devices with this code
Solventum™ Vitrebond™ — Solventum US LLCCalcigel — PREVEST DENPRO LIMITEDNuSmile BioCem Medium Shade — NUSMILE, LTD.CHEMFIL ROCK — Dentsply De Trey GmbHCalcigel — PREVEST DENPRO LIMITEDGC Fuji LINING™ — Gc America Inc.AxioPro ART — Axiodent Inc.Bulk Fill Composite Unit Dose Kit — BISCO INC.MULTI-CAL™ — PULPDENT CORPORATIONTheraCal PT — BISCO INC.Oxford Cal VLC — First Scientific Dental Materials GmbHApaCal ART — PREVEST DENPRO LIMITEDGC Fuji LINING™ — Gc America Inc.Prisma® VLC Dycal® Visible Light Cure Base/Liner Composition — DENTSPLY INTERNATIONAL INC.GC Fuji LINING™ — Gc America Inc.TheraCal LC — BISCO INC.x-tra base — VOCO GmbHDycal® Dentin Radiopaque Calcium Hydroxide Composition — DENTSPLY INTERNATIONAL INC.AxioCAL — Axiodent Inc.ApexPaste Hard — D.S.I DENTAL SOLUTIONS LTDHygenic — COLTENE/WHALEDENT INCBio-LCB — ESSENTIAL DENTAL SYSTEMS, INC.Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCNeoLINER LC 1 g Kit — NUSMILE, LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-06-05 | Axcentria Pharmaceuticals, LLC | One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not inclu |
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