Liner, Cavity, Calcium Hydroxide
FDA product code EJK · Class II (moderate risk) · 21 CFR 872.3250 · Dental
78510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Ultradent Products, Inc. 5
- Sybron Dental Specialties, Inc. 5
- Voco GmbH 4
- Pulpdent Corp. 4
- Bisco, Inc. 4
- Dentsply Intl. 4
- Centrix, Inc. 4
- Espe GmbH (Us) 3
- Ivoclar North America, Inc. 2
- Kerr Corporation (Danbury) 2
- Micro-Vac, Inc. 2
- Kuraray Noritake Dental, Inc. 2
- Specialites Septodont 2
- Coe Laboratories, Inc. 1
- Dental Therapeutics AB 1
- Sybron Corp. 1
- George Taub Products & Fusion Co., Inc. 1
- Mediclus Co., Ltd. 1
- Pennwalt Corp. 1
- Sherwood Medical Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261728 | One-Fil LCEJK · Traditional | Mediclus Co., Ltd. | 07/21/2026SE |
| K253248 | Bright Cavity LinerEJK · Traditional | Dmp Dental Industry S.A. | 01/13/2026SE |
| K230270 | 3M VitCal Liner/BaseEJK · Traditional | 3M Espe Dental Products | 02/06/2023SE |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)EJK · Traditional | Prevest Denpro Limited | 05/13/2022SE |
| K201799 | CleaniCalEJK · Traditional | Maruchi | 02/12/2021SE |
| K202413 | LC ResinCal PCEJK · Traditional | S&C Polymer Silicon- Und Composite Spezialitaten… | 11/20/2020SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | Parkell, Inc. | 11/22/2019SE |
| K180344 | TheraCal DCEJK · Special | Bisco, Inc. | 04/05/2018SE |
| K143292 | TheraCal DCEJK · Traditional | Bisco, Inc. | 08/04/2015SE |
| K150559 | Life Fast Set, Life Regular SetEJK · Special | Sybron Dental Specialties | 06/19/2015SE |
| K141047 | LC Calciumhydroxide LinerEJK · Traditional | S&C Polymer Silicon- Und Composite Spezialitaeten | 04/14/2015SE |
| K134022 | Base ItEJK · Traditional | Spident Co., Ltd. | 06/11/2014SE |
| K131068 | Teethmate Desensitizer Set; Teethmate Desensitizer Powder; Teethmate Desensitizer LiquidEJK · Traditional | Kuraray Noritake Dental, Inc. | 08/27/2013SE |
| K122421 | Teethmate Desensitzer Set Teethmate Desensitizer Powder Teethmate Desensitizer LiquidEJK · Traditional | Kuraray Noritake Dental, Inc. | 12/11/2012SE |
| K120003 | NucalEJK · Traditional | Pulpdent Corporation | 04/05/2012SE |
| K113711 | Lime-Lite IIEJK · Traditional | Pulpdent Corporation | 03/05/2012SE |
| K111668 | Cavios Cavity LinerEJK · Traditional | Neodental Chemical Products Co., Ltd. | 08/19/2011SE |
| K063237 | Theracal LCEJK · Traditional | Bisco, Inc. | 12/08/2006SE |
| K060365 | ApexcalEJK · Traditional | Ivoclar Vivadent, Inc. | 04/17/2006SE |
| K033521 | BisblockEJK · Traditional | Bisco, Inc. | 01/16/2004SE |
| K022025 | Modification to Potassium Nitrate-Polycarboxylate Dental CementEJK · Traditional | Milton Hodosh, M.D. | 08/15/2002SE |
| K021146 | D/Sense 1-STEPEJK · Traditional | Centrix, Inc. | 07/02/2002SE |
| K012717 | Life 2EJK · Traditional | Sybron Dental Specialties, Inc. | 10/25/2001SE |
| K010176 | Calex ConditionerEJK · Traditional | Stephen M Koral, Dmd | 03/27/2001SE |
| K001050 | CalcijectEJK · Traditional | Centrix, Inc. | 07/21/2000SE |
| K983477 | Super SealEJK · Traditional | Phoenix Dental, Inc. | 12/22/1998SE |
| K973539 | Roeko Calcium Hydroxide PointsEJK · Traditional | Roeko USA, Inc. | 10/30/1997SE |
| K970113 | Ultra-Blend PlusEJK · Traditional | Ultradent Products, Inc. | 04/02/1997SE |
| K970114 | Ultracal XSEJK · Traditional | Ultradent Products, Inc. | 03/14/1997SE |
| K964191 | Calcium Hydroxide MedicamentEJK · Traditional | Sybron Dental Specialties, Inc. | 01/22/1997SE |
| K961708 | Life and Life Fast SetEJK · Traditional | Sybron Dental Specialties, Inc. | 05/30/1996SE |
| K953524 | Ultra-BlendEJK · Traditional | Ultradent Products, Inc. | 08/24/1995SE |
| K953079 | LimelightEJK · Traditional | Pulpdent Corp. | 08/07/1995SE |
| K944945 | Pulpdent Calcium Hydroxide PreparationsEJK · Traditional | Pulpdent Corp. | 11/30/1994SE |
| K944416 | LifeEJK · Traditional | Sybron Dental Specialties, Inc. | 11/29/1994SE |
| K943372 | Calcium Hydroxide PasteEJK · Traditional | Ultradent Products, Inc. | 09/19/1994SE |
| K941532 | Biocalex 6/9EJK · Traditional | Bio-Probe, Inc. | 08/02/1994SE |
| K933507 | Needletube Syringe CartrtidgeEJK · Traditional | Centrix, Inc. | 01/18/1994SE |
| K933999 | Steribase (Accubase)EJK · Traditional | Centrix, Inc. | 01/05/1994SE |
| K931502 | Vivaglass LinerEJK · Traditional | Ivoclar North America, Inc. | 07/22/1993SE |
| K926419 | CalcicurEJK · Traditional | Voco GmbH | 03/31/1993SE |
| K921408 | Light Cure Dentin and Liner Base Product LineEJK · Traditional | Ultradent Products, Inc. | 11/24/1992SE |
| K924182 | Calcimol LCEJK · Traditional | Voco GmbH | 10/16/1992SE |
| K923849 | CalcimolEJK · Traditional | Voco GmbH | 09/28/1992SE |
| K922721 | VLC Dycal IIEJK · Traditional | Dentsply Intl. | 07/23/1992SE |
| K920692 | Septocalcine UltraEJK · Traditional | Specialites Septodont | 04/21/1992SE |
| K913574 | Septocal Cavity LinerEJK · Traditional | Specialites Septodont | 09/30/1991SE |
| K912495 | IonosealEJK · Traditional | Voco GmbH | 07/30/1991SE |
| K911244 | VLC Glass Ionomer LinerEJK · Traditional | Dentsply Intl. | 06/28/1991SE |
| K905723 | IonosealEJK · Traditional | Micro-Vac, Inc. | 03/15/1991SE |
| K905724 | IonobondEJK · Traditional | Micro-Vac, Inc. | 02/19/1991SE |
| K904096 | Photac-BondEJK · Traditional | Espe GmbH (Us) | 11/19/1990SE |
| K904097 | Photac-Bond AplicapEJK · Traditional | Espe GmbH (Us) | 11/09/1990SE |
| K901999 | Fuji Lining Cement Light CureEJK · Traditional | G-C Intl. Corp. | 07/31/1990SE |
| K897130 | Interface - Cavity LinerEJK · Traditional | Scientific Pharmaceuticals, Inc. | 03/27/1990SE |
| K896529 | Basic Calcium Hydroxide LinerEJK · Traditional | Ivoclar North America, Inc. | 01/16/1990SE |
| K895508 | Calasept PasteEJK · Traditional | Js Dental Mfg., Inc. | 12/08/1989SE |
| K884949 | Visible Light Cure Calcium Hydroxide LinerEJK · Traditional | Ortho Source | 02/23/1989SE |
| K884245 | Perfect ChoiceEJK · Traditional | Challenge Products, Inc. | 01/04/1989SE |
| K882751 | Glass Ionomer BaseEJK · Traditional | Dentsply Intl. | 11/29/1988SE |
| K873882 | AlkalinerEJK · Traditional | Espe GmbH (Us) | 02/26/1988SE |
| K874194 | Protect Drops/Same AS K874070EJK · Traditional | John O. Butler | 12/16/1987SE |
| K872147 | Kerr CavaliteEJK · Traditional | Kerr Corporation (Danbury) | 08/26/1987SE |
| K864053 | Tubulitec LinerEJK · Traditional | Dental Dimensions Supply Co. | 12/05/1986SE |
| K851053 | Tubulitec LinerEJK · Traditional | Dental Therapeutics AB | 07/25/1985SE |
| K841910 | Kerr Sealapex Root Canal SealerEJK · Traditional | Sybron Corp. | 07/13/1984SE |
| K833640 | HydroxylineEJK · Traditional | George Taub Products & Fusion Co., Inc. | 02/27/1984SE |
| K831575 | Nu-Cap Calcium Hydrox. Pulp CappingEJK · Traditional | Coe Laboratories, Inc. | 06/30/1983SE |
| K830112 | HydrolEJK · Traditional | North Pacific Dental, Inc. | 02/18/1983SE |
| K820215 | Improved DycalEJK · Traditional | Dentsply Intl. | 03/23/1982SE |
| K810266 | Etching GelEJK · Traditional | Espe-Premier Sales Co. | 02/23/1981SE |
| K802685 | ReolitEJK · Traditional | Vivadent (Usa), Inc. | 11/12/1980SE |
| K801860 | S.S. White-Pennwalt Renew Calcium HydroxEJK · Traditional | Pennwalt Corp. | 10/10/1980SE |
| K791088 | Monoject Pulp-Capping MaterialEJK · Traditional | Sherwood Medical Co. | 10/22/1979SE |
| K781688 | Liner, Cavity Calcium HydroxideEJK · Traditional | Kerr Corporation (Danbury) | 12/20/1978SE |
| K780263 | ShieldEJK · Traditional | Lorvic Corp. | 05/03/1978SE |
| K780384 | Improved DycalEJK · Traditional | L.D. Caulk Co. | 03/15/1978SE |
| K760659 | CalcipulpeEJK · Traditional | Septodont, Inc. | 09/27/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2069-2014 Class II | Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional.…One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an… | Axcentria Pharmaceuticals, LLC | 06/05/2014Terminated |