Product Code: EJK FDA class 2 21 CFR 872.3250

Liner, Cavity, Calcium Hydroxide

Dental

The Calcium Hydroxide Cavity Liner is a dental material applied to the floor of a prepared cavity to protect the dental pulp from thermal and chemical irritation, stimulate the formation of secondary dentin, and provide an alkaline, bactericidal environment beneath a restoration. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EJK, regulated under 21 CFR 872.3250 in the Dental (DE) specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EJK
Device Class: FDA class 2
Regulation Number: 872.3250
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 77 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253248	Bright Cavity Liner	Jan 13, 2026	Substantially Equivalent	Dmp Dental Industry S.A.
K230270	3M VitCal Liner/Base	Feb 06, 2023	Substantially Equivalent	3M Espe Dental Products
K212475	Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)	May 13, 2022	Substantially Equivalent	Prevest Denpro Limited
K201799	CleaniCal	Feb 12, 2021	Substantially Equivalent	Maruchi
K202413	LC ResinCal PC	Nov 20, 2020	Substantially Equivalent	S&C Polymer Silicon- Und Composite Spezialitaten GmbH
K191103	Parkell Desensitizer Gel	Nov 22, 2019	Substantially Equivalent	Parkell, Inc.
K180344	TheraCal DC	Apr 05, 2018	Substantially Equivalent	Bisco, Inc.
K143292	TheraCal DC	Aug 04, 2015	Substantially Equivalent	Bisco, Inc.
K150559	Life Fast Set, Life Regular Set	Jun 19, 2015	Substantially Equivalent	Sybron Dental Specialties
K141047	LC CALCIUMHYDROXIDE LINER	Apr 14, 2015	Substantially Equivalent	S&C Polymer Silicon- Und Composite Spezialitaeten
K134022	BASE IT	Jun 11, 2014	Substantially Equivalent	Spident Co., Ltd.
K131068	TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID	Aug 27, 2013	Substantially Equivalent	Kuraray Noritake Dental, Inc.
K122421	TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID	Dec 11, 2012	Substantially Equivalent	Kuraray Noritake Dental, Inc.
K120003	NUCAL	Apr 05, 2012	Substantially Equivalent	Pulpdent Corporation
K113711	LIME-LITE II	Mar 05, 2012	Substantially Equivalent	Pulpdent Corporation
K111668	CAVIOS CAVITY LINER	Aug 19, 2011	Substantially Equivalent	Neodental Chemical Products Co., Ltd.
K063237	THERACAL LC	Dec 08, 2006	Substantially Equivalent	Bisco, Inc.
K060365	APEXCAL	Apr 17, 2006	Substantially Equivalent	Ivoclar Vivadent, Inc.
K033521	BISBLOCK	Jan 16, 2004	Substantially Equivalent	Bisco, Inc.
K022025	MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT	Aug 15, 2002	Substantially Equivalent	Milton Hodosh, M.D.
K021146	D/SENSE 1-STEP	Jul 02, 2002	Substantially Equivalent	Centrix, Inc.
K012717	LIFE 2	Oct 25, 2001	Substantially Equivalent	Sybron Dental Specialties, Inc.
K010176	CALEX CONDITIONER	Mar 27, 2001	Substantially Equivalent	Stephen M Koral, Dmd
K001050	CALCIJECT	Jul 21, 2000	Substantially Equivalent	Centrix, Inc.
K983477	SUPER SEAL	Dec 22, 1998	Substantially Equivalent	Phoenix Dental, Inc.
K973539	ROEKO CALCIUM HYDROXIDE POINTS	Oct 30, 1997	Substantially Equivalent	Roeko USA, Inc.
K970113	ULTRA-BLEND PLUS	Apr 02, 1997	Substantially Equivalent	Ultradent Products, Inc.
K970114	ULTRACAL XS	Mar 14, 1997	Substantially Equivalent	Ultradent Products, Inc.
K964191	CALCIUM HYDROXIDE MEDICAMENT	Jan 22, 1997	Substantially Equivalent	Sybron Dental Specialties, Inc.
K961708	LIFE AND LIFE FAST SET	May 30, 1996	Substantially Equivalent	Sybron Dental Specialties, Inc.
K953524	ULTRA-BLEND	Aug 24, 1995	Substantially Equivalent	Ultradent Products, Inc.
K953079	LIMELIGHT	Aug 07, 1995	Substantially Equivalent	Pulpdent Corp.
K944945	PULPDENT CALCIUM HYDROXIDE PREPARATIONS	Nov 30, 1994	Substantially Equivalent	Pulpdent Corp.
K944416	LIFE	Nov 29, 1994	Substantially Equivalent	Sybron Dental Specialties, Inc.
K943372	CALCIUM HYDROXIDE PASTE	Sep 19, 1994	Substantially Equivalent	Ultradent Products, Inc.
K941532	BIOCALEX 6/9	Aug 02, 1994	Substantially Equivalent	Bio-Probe, Inc.
K933507	NEEDLETUBE SYRINGE CARTRTIDGE	Jan 18, 1994	Substantially Equivalent	Centrix, Inc.
K933999	STERIBASE (ACCUBASE)	Jan 05, 1994	Substantially Equivalent	Centrix, Inc.
K931502	VIVAGLASS LINER	Jul 22, 1993	Substantially Equivalent	Ivoclar North America, Inc.
K926419	CALCICUR	Mar 31, 1993	Substantially Equivalent	Voco GmbH
K921408	LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE	Nov 24, 1992	Substantially Equivalent	Ultradent Products, Inc.
K924182	CALCIMOL LC	Oct 16, 1992	Substantially Equivalent	Voco GmbH
K923849	CALCIMOL	Sep 28, 1992	Substantially Equivalent	Voco GmbH
K922721	VLC DYCAL II	Jul 23, 1992	Substantially Equivalent	Dentsply Intl.
K920692	SEPTOCALCINE ULTRA	Apr 21, 1992	Substantially Equivalent	Specialites Septodont
K913574	SEPTOCAL CAVITY LINER	Sep 30, 1991	Substantially Equivalent	Specialites Septodont
K912495	IONOSEAL	Jul 30, 1991	Substantially Equivalent	Voco GmbH
K911244	VLC GLASS IONOMER LINER	Jun 28, 1991	Substantially Equivalent	Dentsply Intl.
K905723	IONOSEAL	Mar 15, 1991	Substantially Equivalent	Micro-Vac, Inc.
K905724	IONOBOND	Feb 19, 1991	Substantially Equivalent	Micro-Vac, Inc.
K904096	PHOTAC-BOND	Nov 19, 1990	Substantially Equivalent	Espe GmbH (Us)
K904097	PHOTAC-BOND APLICAP	Nov 09, 1990	Substantially Equivalent	Espe GmbH (Us)
K901999	FUJI LINING CEMENT LIGHT CURE	Jul 31, 1990	Substantially Equivalent	G-C Intl. Corp.
K897130	INTERFACE - CAVITY LINER	Mar 27, 1990	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K896529	BASIC CALCIUM HYDROXIDE LINER	Jan 16, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K895508	CALASEPT PASTE	Dec 08, 1989	Substantially Equivalent	Js Dental Mfg., Inc.
K884949	VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER	Feb 23, 1989	Substantially Equivalent	Ortho Source
K884245	PERFECT CHOICE	Jan 04, 1989	Substantially Equivalent	Challenge Products, Inc.
K882751	GLASS IONOMER BASE	Nov 29, 1988	Substantially Equivalent	Dentsply Intl.
K873882	ALKALINER	Feb 26, 1988	Substantially Equivalent	Espe GmbH (Us)
K874194	PROTECT DROPS/SAME AS K874070	Dec 16, 1987	Substantially Equivalent	John O. Butler
K872147	KERR CAVALITE	Aug 26, 1987	Substantially Equivalent	Kerr Corporation (Danbury)
K864053	TUBULITEC LINER	Dec 05, 1986	Substantially Equivalent	Dental Dimensions Supply Co.
K851053	TUBULITEC LINER	Jul 25, 1985	Substantially Equivalent	Dental Therapeutics AB
K841910	KERR SEALAPEX ROOT CANAL SEALER	Jul 13, 1984	Substantially Equivalent	Sybron Corp.
K833640	HYDROXYLINE	Feb 27, 1984	Substantially Equivalent	George Taub Products & Fusion Co., Inc.
K831575	NU-CAP CALCIUM HYDROX. PULP CAPPING	Jun 30, 1983	Substantially Equivalent	Coe Laboratories, Inc.
K830112	HYDROL	Feb 18, 1983	Substantially Equivalent	North Pacific Dental, Inc.
K820215	IMPROVED DYCAL	Mar 23, 1982	Substantially Equivalent	Dentsply Intl.
K810266	ETCHING GEL	Feb 23, 1981	Substantially Equivalent	Espe-Premier Sales Co.
K802685	REOLIT	Nov 12, 1980	Substantially Equivalent	Vivadent (Usa), Inc.
K801860	S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX	Oct 10, 1980	Substantially Equivalent	Pennwalt Corp.
K791088	MONOJECT PULP-CAPPING MATERIAL	Oct 22, 1979	Substantially Equivalent	Sherwood Medical Co.
K781688	LINER, CAVITY CALCIUM HYDROXIDE	Dec 20, 1978	Substantially Equivalent	Kerr Corporation (Danbury)
K780263	SHIELD	May 03, 1978	Substantially Equivalent	Lorvic Corp.
K780384	IMPROVED DYCAL	Mar 15, 1978	Substantially Equivalent	L.D. Caulk Co.
K760659	CALCIPULPE	Sep 27, 1976	Substantially Equivalent	Septodont, Inc.