ClearanceBrief
Panels › Dental › Product code EJK · Class 2

Liner, Cavity, Calcium Hydroxide

Regulation 872.3250

2510(k)s in 12 months (78 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Get daily alerts for EJKSample briefCSV

Top companies in EJK

Company510(k)sRecalls
Sybron Dental Specialties50
Ultradent Products, Inc.50
Bisco, Inc.40
Centrix, Inc.40
Dentsply Intl.40
Pulpdent Corp.40
Voco GmbH40
Espe GmbH (Us)30
Ivoclar North America, Inc.20
Kerr Corporation (Danbury)20
Decided510(k)Device and applicantCode
Jul 21, 2026K261728One-Fil LC
Mediclus Co., Ltd., KR
EJK
Jan 13, 2026K253248Bright Cavity Liner
Dmp Dental Industry S.A., GR
EJK
Feb 6, 2023K2302703M™ VitCal Liner/Base
3M Espe Dental Products
EJK
May 13, 2022K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
Prevest Denpro Limited, IN
EJK
Feb 12, 2021K201799CleaniCal
Maruchi, KR
EJK
Nov 20, 2020K202413LC ResinCal PC
S&C Polymer Silicon- Und Composite Spezialitaten GmbH, DE
EJK
Nov 22, 2019K191103Parkell Desensitizer Gel
Parkell, Inc.
EJK
Apr 5, 2018K180344TheraCal DC
Bisco, Inc.
EJK
Aug 4, 2015K143292TheraCal DC
Bisco, Inc.
EJK
Jun 19, 2015K150559Life Fast Set, Life Regular Set
Sybron Dental Specialties
EJK
Apr 14, 2015K141047LC CALCIUMHYDROXIDE LINER
S&C Polymer Silicon- Und Composite Spezialitaeten, DE
EJK
Jun 11, 2014K134022BASE IT
Spident Co., Ltd.
EJK
Aug 27, 2013K131068TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID
Kuraray Noritake Dental, Inc., JP
EJK
Dec 11, 2012K122421TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID
Kuraray Noritake Dental, Inc., JP
EJK
Apr 5, 2012K120003NUCAL
Pulpdent Corporation
EJK
Mar 5, 2012K113711LIME-LITE II
Pulpdent Corporation
EJK
Aug 19, 2011K111668CAVIOS CAVITY LINER
Neodental Chemical Products Co., Ltd.
EJK
Dec 8, 2006K063237THERACAL LC
Bisco, Inc.
EJK
Apr 17, 2006K060365APEXCAL
Ivoclar Vivadent, Inc.
EJK
Jan 16, 2004K033521BISBLOCK
Bisco, Inc.
EJK
Aug 15, 2002K022025MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
Milton Hodosh, M.D.
EJK
Jul 2, 2002K021146D/SENSE 1-STEP
Centrix, Inc.
EJK
Oct 25, 2001K012717LIFE 2
Sybron Dental Specialties, Inc.
EJK
Mar 27, 2001K010176CALEX CONDITIONER
Stephen M Koral, Dmd
EJK
Jul 21, 2000K001050CALCIJECT
Centrix, Inc.
EJK
Dec 22, 1998K983477SUPER SEAL
Phoenix Dental, Inc.
EJK
Oct 30, 1997K973539ROEKO CALCIUM HYDROXIDE POINTS
Roeko USA, Inc.
EJK
Apr 2, 1997K970113ULTRA-BLEND PLUS
Ultradent Products, Inc.
EJK
Mar 14, 1997K970114ULTRACAL XS
Ultradent Products, Inc.
EJK
Jan 22, 1997K964191CALCIUM HYDROXIDE MEDICAMENT
Sybron Dental Specialties, Inc.
EJK
May 30, 1996K961708LIFE AND LIFE FAST SET
Sybron Dental Specialties, Inc.
EJK
Aug 24, 1995K953524ULTRA-BLEND
Ultradent Products, Inc.
EJK
Aug 7, 1995K953079LIMELIGHT
Pulpdent Corp.
EJK
Nov 30, 1994K944945PULPDENT CALCIUM HYDROXIDE PREPARATIONS
Pulpdent Corp.
EJK
Nov 29, 1994K944416LIFE
Sybron Dental Specialties, Inc.
EJK
Sep 19, 1994K943372CALCIUM HYDROXIDE PASTE
Ultradent Products, Inc.
EJK
Aug 2, 1994K941532BIOCALEX 6/9
Bio-Probe, Inc.
EJK
Jan 18, 1994K933507NEEDLETUBE SYRINGE CARTRTIDGE
Centrix, Inc.
EJK
Jan 5, 1994K933999STERIBASE (ACCUBASE)
Centrix, Inc.
EJK
Jul 22, 1993K931502VIVAGLASS LINER
Ivoclar North America, Inc.
EJK
Mar 31, 1993K926419CALCICUR
Voco GmbH
EJK
Nov 24, 1992K921408LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE
Ultradent Products, Inc.
EJK
Oct 16, 1992K924182CALCIMOL LC
Voco GmbH
EJK
Sep 28, 1992K923849CALCIMOL
Voco GmbH
EJK
Jul 23, 1992K922721VLC DYCAL II
Dentsply Intl.
EJK
Apr 21, 1992K920692SEPTOCALCINE ULTRA
Specialites Septodont
EJK
Sep 30, 1991K913574SEPTOCAL CAVITY LINER
Specialites Septodont
EJK
Jul 30, 1991K912495IONOSEAL
Voco GmbH
EJK
Jun 28, 1991K911244VLC GLASS IONOMER LINER
Dentsply Intl.
EJK
Mar 15, 1991K905723IONOSEAL
Micro-Vac, Inc.
EJK

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.