EJK
78 FDA 510(k) clearances · Product code
77 daysmedian time to decision
163 days90th percentile
78clearances measured
FDA profile
- Official device name
- Liner, Cavity, Calcium Hydroxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3250
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| One-Fil LC (K261728) | Mediclus Co., Ltd. | 2026-07-21 |
| Bright Cavity Liner (K253248) | Dmp Dental Industry S.A. | 2026-01-13 |
| 3M™ VitCal Liner/Base (K230270) | 3M Espe Dental Products | 2023-02-06 |
| Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) (K212475) | Prevest Denpro Limited | 2022-05-13 |
| CleaniCal (K201799) | Maruchi | 2021-02-12 |
| LC ResinCal PC (K202413) | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 2020-11-20 |
| Parkell Desensitizer Gel (K191103) | Parkell, Inc. | 2019-11-22 |
| TheraCal DC (K180344) | Bisco, Inc. | 2018-04-05 |
| TheraCal DC (K143292) | Bisco, Inc. | 2015-08-04 |
| Life Fast Set, Life Regular Set (K150559) | Sybron Dental Specialties | 2015-06-19 |
| LC CALCIUMHYDROXIDE LINER (K141047) | S&C Polymer Silicon- Und Composite Spezialitaeten | 2015-04-14 |
| BASE IT (K134022) | Spident Co., Ltd. | 2014-06-11 |
| TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID (K131068) | Kuraray Noritake Dental, Inc. | 2013-08-27 |
| TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID (K122421) | Kuraray Noritake Dental, Inc. | 2012-12-11 |
| NUCAL (K120003) | Pulpdent Corporation | 2012-04-05 |
| LIME-LITE II (K113711) | Pulpdent Corporation | 2012-03-05 |
| CAVIOS CAVITY LINER (K111668) | Neodental Chemical Products Co., Ltd. | 2011-08-19 |
| THERACAL LC (K063237) | Bisco, Inc. | 2006-12-08 |
| APEXCAL (K060365) | Ivoclar Vivadent, Inc. | 2006-04-17 |
| BISBLOCK (K033521) | Bisco, Inc. | 2004-01-16 |
| MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT (K022025) | Milton Hodosh, M.D. | 2002-08-15 |
| D/SENSE 1-STEP (K021146) | Centrix, Inc. | 2002-07-02 |
| LIFE 2 (K012717) | Sybron Dental Specialties, Inc. | 2001-10-25 |
| CALEX CONDITIONER (K010176) | Stephen M Koral, Dmd | 2001-03-27 |
| CALCIJECT (K001050) | Centrix, Inc. | 2000-07-21 |
| SUPER SEAL (K983477) | Phoenix Dental, Inc. | 1998-12-22 |
| ROEKO CALCIUM HYDROXIDE POINTS (K973539) | Roeko USA, Inc. | 1997-10-30 |
| ULTRA-BLEND PLUS (K970113) | Ultradent Products, Inc. | 1997-04-02 |
| ULTRACAL XS (K970114) | Ultradent Products, Inc. | 1997-03-14 |
| CALCIUM HYDROXIDE MEDICAMENT (K964191) | Sybron Dental Specialties, Inc. | 1997-01-22 |
| LIFE AND LIFE FAST SET (K961708) | Sybron Dental Specialties, Inc. | 1996-05-30 |
| ULTRA-BLEND (K953524) | Ultradent Products, Inc. | 1995-08-24 |
| LIMELIGHT (K953079) | Pulpdent Corp. | 1995-08-07 |
| PULPDENT CALCIUM HYDROXIDE PREPARATIONS (K944945) | Pulpdent Corp. | 1994-11-30 |
| LIFE (K944416) | Sybron Dental Specialties, Inc. | 1994-11-29 |
| CALCIUM HYDROXIDE PASTE (K943372) | Ultradent Products, Inc. | 1994-09-19 |
| BIOCALEX 6/9 (K941532) | Bio-Probe, Inc. | 1994-08-02 |
| NEEDLETUBE SYRINGE CARTRTIDGE (K933507) | Centrix, Inc. | 1994-01-18 |
| STERIBASE (ACCUBASE) (K933999) | Centrix, Inc. | 1994-01-05 |
| VIVAGLASS LINER (K931502) | Ivoclar North America, Inc. | 1993-07-22 |
| CALCICUR (K926419) | Voco GmbH | 1993-03-31 |
| LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE (K921408) | Ultradent Products, Inc. | 1992-11-24 |
| CALCIMOL LC (K924182) | Voco GmbH | 1992-10-16 |
| CALCIMOL (K923849) | Voco GmbH | 1992-09-28 |
| VLC DYCAL II (K922721) | Dentsply Intl. | 1992-07-23 |
| SEPTOCALCINE ULTRA (K920692) | Specialites Septodont | 1992-04-21 |
| SEPTOCAL CAVITY LINER (K913574) | Specialites Septodont | 1991-09-30 |
| IONOSEAL (K912495) | Voco GmbH | 1991-07-30 |
| VLC GLASS IONOMER LINER (K911244) | Dentsply Intl. | 1991-06-28 |
| IONOSEAL (K905723) | Micro-Vac, Inc. | 1991-03-15 |
| IONOBOND (K905724) | Micro-Vac, Inc. | 1991-02-19 |
| PHOTAC-BOND (K904096) | Espe GmbH (Us) | 1990-11-19 |
| PHOTAC-BOND APLICAP (K904097) | Espe GmbH (Us) | 1990-11-09 |
| FUJI LINING CEMENT LIGHT CURE (K901999) | G-C Intl. Corp. | 1990-07-31 |
| INTERFACE - CAVITY LINER (K897130) | Scientific Pharmaceuticals, Inc. | 1990-03-27 |
| BASIC CALCIUM HYDROXIDE LINER (K896529) | Ivoclar North America, Inc. | 1990-01-16 |
| CALASEPT PASTE (K895508) | Js Dental Mfg., Inc. | 1989-12-08 |
| VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER (K884949) | Ortho Source | 1989-02-23 |
| PERFECT CHOICE (K884245) | Challenge Products, Inc. | 1989-01-04 |
| GLASS IONOMER BASE (K882751) | Dentsply Intl. | 1988-11-29 |
| ALKALINER (K873882) | Espe GmbH (Us) | 1988-02-26 |
| PROTECT DROPS/SAME AS K874070 (K874194) | John O. Butler | 1987-12-16 |
| KERR CAVALITE (K872147) | Kerr Corporation (Danbury) | 1987-08-26 |
| TUBULITEC LINER (K864053) | Dental Dimensions Supply Co. | 1986-12-05 |
| TUBULITEC LINER (K851053) | Dental Therapeutics AB | 1985-07-25 |
| KERR SEALAPEX ROOT CANAL SEALER (K841910) | Sybron Corp. | 1984-07-13 |
| HYDROXYLINE (K833640) | George Taub Products & Fusion Co., Inc. | 1984-02-27 |
| NU-CAP CALCIUM HYDROX. PULP CAPPING (K831575) | Coe Laboratories, Inc. | 1983-06-30 |
| HYDROL (K830112) | North Pacific Dental, Inc. | 1983-02-18 |
| IMPROVED DYCAL (K820215) | Dentsply Intl. | 1982-03-23 |
| ETCHING GEL (K810266) | Espe-Premier Sales Co. | 1981-02-23 |
| REOLIT (K802685) | Vivadent (Usa), Inc. | 1980-11-12 |
| S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX (K801860) | Pennwalt Corp. | 1980-10-10 |
| MONOJECT PULP-CAPPING MATERIAL (K791088) | Sherwood Medical Co. | 1979-10-22 |
| LINER, CAVITY CALCIUM HYDROXIDE (K781688) | Kerr Corporation (Danbury) | 1978-12-20 |
| SHIELD (K780263) | Lorvic Corp. | 1978-05-03 |
| IMPROVED DYCAL (K780384) | L.D. Caulk Co. | 1978-03-15 |
| CALCIPULPE (K760659) | Septodont, Inc. | 1976-09-27 |
Track EJK automatically
Every clearance here is in the API, with alerts when new ones post.