Liner, Cavity, Calcium Hydroxide
FDA product code EJK · 74 cleared devices
Class 2
Dental
- Regulation
- 21 CFR 872.3250
- Review panel
- DE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-09-27 – 2026-07-21
EJK
2026-07-21
EJK
2026-01-13
Bright Cavity Liner
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EJK
2023-02-06
3M™ VitCal Liner/Base
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EJK
2022-05-13
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
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EJK
2021-02-12
CleaniCal
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EJK
2020-11-20
LC ResinCal PC
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EJK
2019-11-22
Parkell Desensitizer Gel
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EJK
2018-04-05
TheraCal DC
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EJK
2013-08-27
TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID
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EJK
2012-12-11
TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID
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EJK
2012-04-05
NUCAL
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EJK
2012-03-05
LIME-LITE II
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EJK
2011-08-19
CAVIOS CAVITY LINER
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EJK
2006-12-08
THERACAL LC
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EJK
2006-04-17
APEXCAL
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EJK
2004-01-16
BISBLOCK
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EJK
2002-08-15
MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
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EJK
2002-07-02
D/SENSE 1-STEP
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EJK
2001-10-25
LIFE 2
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EJK
2001-03-27
CALEX CONDITIONER
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EJK
2000-07-21
CALCIJECT
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EJK
1998-12-22
SUPER SEAL
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EJK
1997-10-30
ROEKO CALCIUM HYDROXIDE POINTS
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EJK
1997-04-02
ULTRA-BLEND PLUS
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EJK
1997-03-14
ULTRACAL XS
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EJK
1997-01-22
CALCIUM HYDROXIDE MEDICAMENT
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EJK
1996-05-30
LIFE AND LIFE FAST SET
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EJK
1995-08-24
ULTRA-BLEND
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EJK
1995-08-07
LIMELIGHT
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EJK
1994-11-30
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
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EJK
1994-11-29
LIFE
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EJK
1994-09-19
CALCIUM HYDROXIDE PASTE
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EJK
1994-08-02
BIOCALEX 6/9
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EJK
1994-01-18
NEEDLETUBE SYRINGE CARTRTIDGE
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EJK
1994-01-05
STERIBASE (ACCUBASE)
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EJK
1993-07-22
VIVAGLASS LINER
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EJK
1993-03-31
CALCICUR
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EJK
1992-11-24
LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE
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EJK
1992-10-16
CALCIMOL LC
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EJK
1992-09-28
CALCIMOL
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EJK
1992-07-23
VLC DYCAL II
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EJK
1992-04-21
SEPTOCALCINE ULTRA
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EJK
1991-09-30
SEPTOCAL CAVITY LINER
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EJK
1991-07-30
IONOSEAL
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EJK
1991-06-28
VLC GLASS IONOMER LINER
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EJK
1991-03-15
IONOSEAL
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EJK
1991-02-19
IONOBOND
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EJK
1990-11-19
PHOTAC-BOND
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EJK
1990-11-09
PHOTAC-BOND APLICAP
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EJK
1990-07-31
FUJI LINING CEMENT LIGHT CURE
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EJK
1990-03-27
INTERFACE - CAVITY LINER
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EJK
1990-01-16
BASIC CALCIUM HYDROXIDE LINER
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EJK
1989-12-08
CALASEPT PASTE
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EJK
1989-02-23
VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER
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EJK
1989-01-04
PERFECT CHOICE
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EJK
1988-11-29
GLASS IONOMER BASE
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EJK
1988-02-26
ALKALINER
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EJK
1987-12-16
PROTECT DROPS/SAME AS K874070
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EJK
1987-08-26
KERR CAVALITE
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EJK
1986-12-05
TUBULITEC LINER
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EJK
1985-07-25
TUBULITEC LINER
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EJK
1984-07-13
KERR SEALAPEX ROOT CANAL SEALER
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EJK
1984-02-27
HYDROXYLINE
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EJK
1983-06-30
NU-CAP CALCIUM HYDROX. PULP CAPPING
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EJK
1983-02-18
HYDROL
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EJK
1982-03-23
IMPROVED DYCAL
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EJK
1981-02-23
ETCHING GEL
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EJK
1980-11-12
REOLIT
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EJK
1980-10-10
S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX
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EJK
1979-10-22
MONOJECT PULP-CAPPING MATERIAL
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EJK
1978-12-20
LINER, CAVITY CALCIUM HYDROXIDE
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EJK
1978-05-03
SHIELD
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EJK
1978-03-15
IMPROVED DYCAL
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EJK
1976-09-27
CALCIPULPE
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