FDA Product Code
FDA Product Code EJK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3250
510(k) Clearances — 78 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261728 | One-Fil LC | Mediclus Co., Ltd. | 2026-07-21 | Traditional | PDF ↗ |
| K253248 | Bright Cavity Liner | Dmp Dental Industry S.A. | 2026-01-13 | Traditional | PDF ↗ |
| K230270 | 3M VitCal Liner/Base | 3M Espe Dental Products | 2023-02-06 | Traditional | PDF ↗ |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | 2022-05-13 | Traditional | PDF ↗ |
| K201799 | CleaniCal | Maruchi | 2021-02-12 | Traditional | PDF ↗ |
| K202413 | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 2020-11-20 | Traditional | PDF ↗ |
| K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019-11-22 | Traditional | PDF ↗ |
| K180344 | TheraCal DC | Bisco, Inc. | 2018-04-05 | Special | PDF ↗ |
| K143292 | TheraCal DC | Bisco, Inc. | 2015-08-04 | Traditional | PDF ↗ |
| K150559 | Life Fast Set, Life Regular Set | Sybron Dental Specialties | 2015-06-19 | Special | PDF ↗ |
| K141047 | LC CALCIUMHYDROXIDE LINER | S&C Polymer Silicon- Und Composite Spezialitaeten | 2015-04-14 | Traditional | PDF ↗ |
| K134022 | BASE IT | Spident Co., Ltd. | 2014-06-11 | Traditional | PDF ↗ |
| K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | 2013-08-27 | Traditional | PDF ↗ |
| K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | 2012-12-11 | Traditional | PDF ↗ |
| K120003 | NUCAL | Pulpdent Corporation | 2012-04-05 | Traditional | PDF ↗ |
| K113711 | LIME-LITE II | Pulpdent Corporation | 2012-03-05 | Traditional | PDF ↗ |
| K111668 | CAVIOS CAVITY LINER | Neodental Chemical Products Co., Ltd. | 2011-08-19 | Traditional | PDF ↗ |
| K063237 | THERACAL LC | Bisco, Inc. | 2006-12-08 | Traditional | PDF ↗ |
| K060365 | APEXCAL | Ivoclar Vivadent, Inc. | 2006-04-17 | Traditional | PDF ↗ |
| K033521 | BISBLOCK | Bisco, Inc. | 2004-01-16 | Traditional | PDF ↗ |
| K022025 | MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT | Milton Hodosh, M.D. | 2002-08-15 | Traditional | PDF ↗ |
| K021146 | D/SENSE 1-STEP | Centrix, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K012717 | LIFE 2 | Sybron Dental Specialties, Inc. | 2001-10-25 | Traditional | PDF ↗ |
| K010176 | CALEX CONDITIONER | Stephen M Koral, Dmd | 2001-03-27 | Traditional | PDF ↗ |
| K001050 | CALCIJECT | Centrix, Inc. | 2000-07-21 | Traditional | PDF ↗ |
| K983477 | SUPER SEAL | Phoenix Dental, Inc. | 1998-12-22 | Traditional | PDF ↗ |
| K973539 | ROEKO CALCIUM HYDROXIDE POINTS | Roeko USA, Inc. | 1997-10-30 | Traditional | PDF ↗ |
| K970113 | ULTRA-BLEND PLUS | Ultradent Products, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K970114 | ULTRACAL XS | Ultradent Products, Inc. | 1997-03-14 | Traditional | PDF ↗ |
| K964191 | CALCIUM HYDROXIDE MEDICAMENT | Sybron Dental Specialties, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K961708 | LIFE AND LIFE FAST SET | Sybron Dental Specialties, Inc. | 1996-05-30 | Traditional | PDF ↗ |
| K953524 | ULTRA-BLEND | Ultradent Products, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K953079 | LIMELIGHT | Pulpdent Corp. | 1995-08-07 | Traditional | PDF ↗ |
| K944945 | PULPDENT CALCIUM HYDROXIDE PREPARATIONS | Pulpdent Corp. | 1994-11-30 | Traditional | PDF ↗ |
| K944416 | LIFE | Sybron Dental Specialties, Inc. | 1994-11-29 | Traditional | PDF ↗ |
| K943372 | CALCIUM HYDROXIDE PASTE | Ultradent Products, Inc. | 1994-09-19 | Traditional | PDF ↗ |
| K941532 | BIOCALEX 6/9 | Bio-Probe, Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K933507 | NEEDLETUBE SYRINGE CARTRTIDGE | Centrix, Inc. | 1994-01-18 | Traditional | PDF ↗ |
| K933999 | STERIBASE (ACCUBASE) | Centrix, Inc. | 1994-01-05 | Traditional | PDF ↗ |
| K931502 | VIVAGLASS LINER | Ivoclar North America, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K926419 | CALCICUR | Voco GmbH | 1993-03-31 | Traditional | PDF ↗ |
| K921408 | LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE | Ultradent Products, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K924182 | CALCIMOL LC | Voco GmbH | 1992-10-16 | Traditional | PDF ↗ |
| K923849 | CALCIMOL | Voco GmbH | 1992-09-28 | Traditional | PDF ↗ |
| K922721 | VLC DYCAL II | Dentsply Intl. | 1992-07-23 | Traditional | PDF ↗ |
| K920692 | SEPTOCALCINE ULTRA | Specialites Septodont | 1992-04-21 | Traditional | PDF ↗ |
| K913574 | SEPTOCAL CAVITY LINER | Specialites Septodont | 1991-09-30 | Traditional | PDF ↗ |
| K912495 | IONOSEAL | Voco GmbH | 1991-07-30 | Traditional | PDF ↗ |
| K911244 | VLC GLASS IONOMER LINER | Dentsply Intl. | 1991-06-28 | Traditional | PDF ↗ |
| K905723 | IONOSEAL | Micro-Vac, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K905724 | IONOBOND | Micro-Vac, Inc. | 1991-02-19 | Traditional | PDF ↗ |
| K904096 | PHOTAC-BOND | Espe GmbH (Us) | 1990-11-19 | Traditional | PDF ↗ |
| K904097 | PHOTAC-BOND APLICAP | Espe GmbH (Us) | 1990-11-09 | Traditional | PDF ↗ |
| K901999 | FUJI LINING CEMENT LIGHT CURE | G-C Intl. Corp. | 1990-07-31 | Traditional | PDF ↗ |
| K897130 | INTERFACE - CAVITY LINER | Scientific Pharmaceuticals, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K896529 | BASIC CALCIUM HYDROXIDE LINER | Ivoclar North America, Inc. | 1990-01-16 | Traditional | PDF ↗ |
| K895508 | CALASEPT PASTE | Js Dental Mfg., Inc. | 1989-12-08 | Traditional | PDF ↗ |
| K884949 | VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER | Ortho Source | 1989-02-23 | Traditional | PDF ↗ |
| K884245 | PERFECT CHOICE | Challenge Products, Inc. | 1989-01-04 | Traditional | PDF ↗ |
| K882751 | GLASS IONOMER BASE | Dentsply Intl. | 1988-11-29 | Traditional | PDF ↗ |
| K873882 | ALKALINER | Espe GmbH (Us) | 1988-02-26 | Traditional | PDF ↗ |
| K874194 | PROTECT DROPS/SAME AS K874070 | John O. Butler | 1987-12-16 | Traditional | PDF ↗ |
| K872147 | KERR CAVALITE | Kerr Corporation (Danbury) | 1987-08-26 | Traditional | PDF ↗ |
| K864053 | TUBULITEC LINER | Dental Dimensions Supply Co. | 1986-12-05 | Traditional | PDF ↗ |
| K851053 | TUBULITEC LINER | Dental Therapeutics AB | 1985-07-25 | Traditional | PDF ↗ |
| K841910 | KERR SEALAPEX ROOT CANAL SEALER | Sybron Corp. | 1984-07-13 | Traditional | PDF ↗ |
| K833640 | HYDROXYLINE | George Taub Products & Fusion Co., Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K831575 | NU-CAP CALCIUM HYDROX. PULP CAPPING | Coe Laboratories, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K830112 | HYDROL | North Pacific Dental, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K820215 | IMPROVED DYCAL | Dentsply Intl. | 1982-03-23 | Traditional | PDF ↗ |
| K810266 | ETCHING GEL | Espe-Premier Sales Co. | 1981-02-23 | Traditional | PDF ↗ |
| K802685 | REOLIT | Vivadent (Usa), Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K801860 | S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX | Pennwalt Corp. | 1980-10-10 | Traditional | PDF ↗ |
| K791088 | MONOJECT PULP-CAPPING MATERIAL | Sherwood Medical Co. | 1979-10-22 | Traditional | PDF ↗ |
| K781688 | LINER, CAVITY CALCIUM HYDROXIDE | Kerr Corporation (Danbury) | 1978-12-20 | Traditional | PDF ↗ |
| K780263 | SHIELD | Lorvic Corp. | 1978-05-03 | Traditional | PDF ↗ |
| K780384 | IMPROVED DYCAL | L.D. Caulk Co. | 1978-03-15 | Traditional | PDF ↗ |
| K760659 | CALCIPULPE | Septodont, Inc. | 1976-09-27 | Traditional | PDF ↗ |
Product code EJK · Class II · Dental. Data: openFDA.