Dental Device Guide
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Prosthetic devices · 21 CFR 872 Subpart D

Calcium Hydroxide Cavity Liner

FDA device type “Liner, Cavity, Calcium Hydroxide”.

FDA codeEJKClass221 CFR872.3250Pathway510(k)
Companies listing it
4326 makers
Brands and models
63
510(k) clearances
784 in five years
FDA name
Liner, Cavity, Calcium Hydroxide
1976: 11978: 31979: 11980: 21981: 11982: 11983: 21984: 21985: 11986: 11987: 21988: 21989: 31990: 51991: 51992: 51993: 21994: 61995: 21996: 11997: 41998: 12000: 12001: 22002: 22004: 12006: 22011: 12012: 32013: 12014: 12015: 32018: 12019: 12020: 12021: 12022: 12023: 12026: 219801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EJK

43 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMakerDycal Calcium Hydroxide1482026
Mediclus Co., LtdSouth KoreaMakerOne-Fil LC152026
Spident Co., Ltd.South KoreaMakerBase It222026
Voco GmbHGermanyMakerCalcicur · Calcimol · Calcimol LC · Ionoseal1172026
GC America Inc.United StatesMakerFUJI LINING CEMENT LIGHT CURE1372026
Sybron Dental SpecialtiesUnited StatesMakerLife2032026
Ultradent Products, Inc.United StatesMakerUltraBlend Plus · UltraCal XS952026
Prevest Denpro LimitedIndiaMakerApacal ART · Cal LC · Calcigel · CalUltra72024
Kuraray Noritake Dental, Inc.JapanMakerTEETHMATE DESENSITIZER322025
Guilin Kevin Peter Technology Co., Ltd.ChinaMakerCalcium Hydroxide Temporary Filling Material (KP-Cal )32026
Bisco, Inc.United StatesMakerTHERACAL LC · TheraCal PT882025
Parkell, IncUnited StatesMaker—582025
Imicryl Dis Malzemeleri Sanayi VE Ticaret ASTürkiyeMakerNova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe · Nova Compo HF, Othocompo, Luxera, Maritza52022
DMP Dental Industry S.A.GreeceMakerBright Cavity Liner32026
MaruchiSouth KoreaMakerCleaniCal82023
NuSmile, Ltd.United StatesMakerNeoLINER · NuSmile BioCem · NuSmile NeoPEX22026
Pulpdent CorporationUnited StatesMakerACTIVA BioACTIVE BASE / LINER · ACTIVA BioACTIVE CEMENT · Lime-Lite · Multi-Cal Calcium Hydroxide Paste · +41072021
Scientific PharmaceuticalsUnited StatesMakerInterface732020
S & C Polymer GmbHGermanyMaker—202009
Neodental Chemical Products Co., Ltd.JapanMakerCavios52011
George Taub Products & Fusion Co., Inc.United StatesMakerHYDROXYLINE · HYDROXYLINE TC21986
Temrex Corp.United StatesMakerINTERFACE22012
Directa ABSwedenMakerCalasept, CalaseptPlus · Ceramir Protect LC12015
Identa Dental Material GmbHGermanyMakerIDENTA Calcium SC - in tubes · IDENTA Calcium water-based · IDENTA LC GIC Composite——
Solventum US LLCUnited StatesMaker———
Viarden Lab LLCUnited StatesMakerCALCIUM HYDROXIDE VIARDEN LAB, HYDROXY PASTE, VIARPEX, VIARBLEND——
Centrix, Inc.United StatesContract manufacturerCalciject442025
Essential Dental Systems, Inc.United StatesRepacker / relabelerBio-LCB152023
DSI Dental Solutions LtdIsraelManufacturerApexPaste · ApexPaste Bio · ApexPaste Hard · ApexPaste I · +122025
Engineered EndodonticsUnited StatesRepacker / relabelerActaCal Paste12019
Sotera Health LLCUnited StatesContract manufacturer———
Jersey Dental SuppliesUnited StatesRepacker / relabelerULTRACAL XS——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerDental cement · dental liner · Liner——
Soher Med LimitedHong Kong SAR ChinaForeign exporterCalcimol · dental cement · Liner · Tooth shade——
Axiodent Inc.United StatesRepacker / relabeler———
E/T Endodontic Technologies, Ltd.CanadaForeign exporterMulti-Cal——
HI Medical Co., Ltd.South KoreaForeign exporterDentsply——
Sanicure BVNetherlandsForeign exporter———
Zapalign LLCUnited StatesRepacker / relabeler———
Evolve Dental Technologies, Inc.United StatesRepacker / relabeler———
Kash Sales Inc.CanadaForeign exporter———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
21 Jul 2026K261728One-Fil LCMediclus Co., Ltd
13 Jan 2026K253248Bright Cavity LinerDMP Dental Industry S.A.
6 Feb 2023K2302703M™ VitCal Liner/Base3M Espe Dental Products
13 May 2022K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited
12 Feb 2021K201799CleaniCalMaruchi
20 Nov 2020K202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH
22 Nov 2019K191103Parkell Desensitizer GelParkell, Inc
5 Apr 2018K180344TheraCal DCBisco, Inc.
4 Aug 2015K143292TheraCal DCBisco, Inc.
19 Jun 2015K150559Life Fast Set, Life Regular SetSybron Dental Specialties
14 Apr 2015K141047LC CALCIUMHYDROXIDE LINERS&C Polymer Silicon- Und Composite Spezialitaeten GmbH
11 Jun 2014K134022BASE ITSpident Co., Ltd.
27 Aug 2013K131068TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUIDKuraray Noritake Dental, Inc.
11 Dec 2012K122421TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUIDKuraray Noritake Dental, Inc.
5 Apr 2012K120003NUCALPulpdent Corporation
5 Mar 2012K113711LIME-LITE IIPulpdent Corporation
19 Aug 2011K111668CAVIOS CAVITY LINERNeodental Chemical Products Co., Ltd.
8 Dec 2006K063237THERACAL LCBisco, Inc.
17 Apr 2006K060365APEXCALIvoclar Vivadent, AG
16 Jan 2004K033521BISBLOCKBisco, Inc.
15 Aug 2002K022025MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENTMilton Hodosh, M.D.
2 Jul 2002K021146D/SENSE 1-STEPCentrix, Inc.
25 Oct 2001K012717LIFE 2Sybron Dental Specialties
27 Mar 2001K010176CALEX CONDITIONERStephen M Koral, Dmd
21 Jul 2000K001050CALCIJECTCentrix, Inc.
22 Dec 1998K983477SUPER SEALPhoenix Dental, Inc.
30 Oct 1997K973539ROEKO CALCIUM HYDROXIDE POINTSRoeko USA, Inc.
2 Apr 1997K970113ULTRA-BLEND PLUSUltradent Products, Inc.
14 Mar 1997K970114ULTRACAL XSUltradent Products, Inc.
22 Jan 1997K964191CALCIUM HYDROXIDE MEDICAMENTSybron Dental Specialties
30 May 1996K961708LIFE AND LIFE FAST SETSybron Dental Specialties
24 Aug 1995K953524ULTRA-BLENDUltradent Products, Inc.
7 Aug 1995K953079LIMELIGHTPulpdent Corporation
30 Nov 1994K944945PULPDENT CALCIUM HYDROXIDE PREPARATIONSPulpdent Corporation
29 Nov 1994K944416LIFESybron Dental Specialties
19 Sep 1994K943372CALCIUM HYDROXIDE PASTEUltradent Products, Inc.
2 Aug 1994K941532BIOCALEX 6/9Bio-Probe, Inc.
18 Jan 1994K933507NEEDLETUBE SYRINGE CARTRTIDGECentrix, Inc.
5 Jan 1994K933999STERIBASE (ACCUBASE)Centrix, Inc.
22 Jul 1993K931502VIVAGLASS LINERIvoclar North America, Inc.
31 Mar 1993K926419CALCICURVoco GmbH
24 Nov 1992K921408LIGHT CURE DENTIN AND LINER BASE PRODUCT LINEUltradent Products, Inc.
16 Oct 1992K924182CALCIMOL LCVoco GmbH
28 Sep 1992K923849CALCIMOLVoco GmbH
23 Jul 1992K922721VLC DYCAL IIDentsply Intl., Inc.
21 Apr 1992K920692SEPTOCALCINE ULTRASpecialites Septodont
30 Sep 1991K913574SEPTOCAL CAVITY LINERSpecialites Septodont
30 Jul 1991K912495IONOSEALVoco GmbH
28 Jun 1991K911244VLC GLASS IONOMER LINERDentsply Intl., Inc.
15 Mar 1991K905723IONOSEALMicro-Vac, Inc.
19 Feb 1991K905724IONOBONDMicro-Vac, Inc.
19 Nov 1990K904096PHOTAC-BONDEspe GmbH (Us)
9 Nov 1990K904097PHOTAC-BOND APLICAPEspe GmbH (Us)
31 Jul 1990K901999FUJI LINING CEMENT LIGHT CUREG-C Intl. Corp.
27 Mar 1990K897130INTERFACE - CAVITY LINERScientific Pharmaceuticals
16 Jan 1990K896529BASIC CALCIUM HYDROXIDE LINERIvoclar North America, Inc.
8 Dec 1989K895508CALASEPT PASTEJs Dental Mfg., Inc.
23 Feb 1989K884949VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINEROrtho Source
4 Jan 1989K884245PERFECT CHOICEChallenge Products, Inc.
29 Nov 1988K882751GLASS IONOMER BASEDentsply Intl., Inc.
26 Feb 1988K873882ALKALINEREspe GmbH (Us)
16 Dec 1987K874194PROTECT DROPS/SAME AS K874070John O. Butler Co.
26 Aug 1987K872147KERR CAVALITEKerr Corporation (Danbury)
5 Dec 1986K864053TUBULITEC LINERDental Dimensions Supply Co.
25 Jul 1985K851053TUBULITEC LINERDental Therapeutics AB
13 Jul 1984K841910KERR SEALAPEX ROOT CANAL SEALERSybron Corp.
27 Feb 1984K833640HYDROXYLINEGeorge Taub Products & Fusion Co., Inc.
30 Jun 1983K831575NU-CAP CALCIUM HYDROX. PULP CAPPINGCoe Laboratories, Inc.
18 Feb 1983K830112HYDROLNorth Pacific Dental, Inc.
23 Mar 1982K820215IMPROVED DYCALDentsply Intl., Inc.
23 Feb 1981K810266ETCHING GELEspe-Premier Sales Co.
12 Nov 1980K802685REOLITVivadent (Usa), Inc.
10 Oct 1980K801860S.S. WHITE-PENNWALT RENEW CALCIUM HYDROXPennwalt Corp.
22 Oct 1979K791088MONOJECT PULP-CAPPING MATERIALSherwood Medical Co.
20 Dec 1978K781688LINER, CAVITY CALCIUM HYDROXIDEKerr Corporation (Danbury)
3 May 1978K780263SHIELDLorvic Corp.
15 Mar 1978K780384IMPROVED DYCALL.D. Caulk Co.
27 Sep 1976K760659CALCIPULPESeptodont

Official records: FDA product classification for EJK · 21 CFR 872.3250.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026