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
Bio-LCB — ESSENTIAL DENTAL SYSTEMS, INC.Calcigel — PREVEST DENPRO LIMITEDTEMPCANAL™ — PULPDENT CORPORATIONActiva BioActive-Base/Liner Sample — PULPDENT CORPORATIONROEKO Calcium Hydroxide PLUS Points — Coltène/Whaledent GmbH + Co. KGTheraCal LC — BISCO INC.TheraCal LC — BISCO INC.TheraCal LC — BISCO INC.AxioCAL — Axiodent Inc.ACTIVA™ Bio-ACTIVE-CEMENT™ — PULPDENT CORPORATIONGC Fuji LINING™ — Gc America Inc.ROEKO Calcium Hydroxide PLUS Points — Coltène/Whaledent GmbH + Co. KGCalasept® — Directa ABApexPaste — D.S.I DENTAL SOLUTIONS LTDx-tra base — VOCO GmbHCalcigel — PREVEST DENPRO LIMITEDx-tra base — VOCO GmbHPredicta™ — PARKELL, INC.INTERFACE — TEMREX CORPORATIONCalasept®Plus — Directa ABHygenic — COLTENE/WHALEDENT INCTheraCal LC — BISCO INC.Bosworth Hydrox — Harry J Bosworth CompanyTrueCal™ 35% Calcium Hydroxide Paste 4pk — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
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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