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EJK — Liner, Cavity, Calcium Hydroxide Class II

FDA Device Classification

FDA product code EJK covers "Liner, Cavity, Calcium Hydroxide", a Class II medical device regulated under 21 CFR 872.3250. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EJK
Device Class
Class II
Regulation Number
872.3250
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K261728Mediclus CoOne-Fil LCJul 21, 2026
K253248Dmp Dental IndustryBright Cavity LinerJan 13, 2026
K2302703M Espe Dental Products3M™ VitCal Liner/BaseFeb 6, 2023
K212475Prevest Denpro LimitedPrevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)May 13, 2022
K201799MaruchiCleaniCalFeb 12, 2021
K202413S And C Polymer Silicon- Und Composite SpezialitatenLC ResinCal PCNov 20, 2020
K191103ParkellParkell Desensitizer GelNov 22, 2019
K180344BiscoTheraCal DCApr 5, 2018
K143292BiscoTheraCal DCAug 4, 2015
K150559Sybron Dental SpecialtiesLife Fast Set, Life Regular SetJun 19, 2015
K141047S And C Polymer Silicon- Und Composite SpezialitaetenLC CALCIUMHYDROXIDE LINERApr 14, 2015
K134022Spident CoBASE ITJun 11, 2014
K131068Kuraray Noritake DentalTEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZEAug 27, 2013
K122421Kuraray Noritake DentalTEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LDec 11, 2012
K120003Pulpdent CorporationNUCALApr 5, 2012
K113711Pulpdent CorporationLIME-LITE IIMar 5, 2012
K111668Neodental Chemical Products CoCAVIOS CAVITY LINERAug 19, 2011
K063237BiscoTHERACAL LCDec 8, 2006
K060365Ivoclar VivadentAPEXCALApr 17, 2006
K033521BiscoBISBLOCKJan 16, 2004

FDA data resources