Product code EJK
- Device name
- Liner, Cavity, Calcium Hydroxide
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3250
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253248 | Bright Cavity Liner | Dmp Dental Industry S.A. | 2026-01-13 |
| K230270 | 3M™ VitCal Liner/Base | 3M Espe Dental Products | 2023-02-06 |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | 2022-05-13 |
| K201799 | CleaniCal | Maruchi | 2021-02-12 |
| K202413 | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 2020-11-20 |
| K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019-11-22 |
| K180344 | TheraCal DC | Bisco, Inc. | 2018-04-05 |
| K143292 | TheraCal DC | Bisco, Inc. | 2015-08-04 |
| K150559 | Life Fast Set, Life Regular Set | Sybron Dental Specialties | 2015-06-19 |
| K141047 | LC CALCIUMHYDROXIDE LINER | S&C Polymer Silicon- Und Composite Spezialitaeten | 2015-04-14 |
| K134022 | BASE IT | Spident Co., Ltd. | 2014-06-11 |
| K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | 2013-08-27 |
| K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | 2012-12-11 |
| K120003 | NUCAL | Pulpdent Corporation | 2012-04-05 |
| K113711 | LIME-LITE II | Pulpdent Corporation | 2012-03-05 |
| K111668 | CAVIOS CAVITY LINER | Neodental Chemical Products Co., Ltd. | 2011-08-19 |
| K063237 | THERACAL LC | Bisco, Inc. | 2006-12-08 |
| K060365 | APEXCAL | Ivoclar Vivadent, Inc. | 2006-04-17 |
| K033521 | BISBLOCK | Bisco, Inc. | 2004-01-16 |
| K022025 | MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT | Milton Hodosh, M.D. | 2002-08-15 |
| K021146 | D/SENSE 1-STEP | Centrix, Inc. | 2002-07-02 |
| K012717 | LIFE 2 | Sybron Dental Specialties, Inc. | 2001-10-25 |
| K010176 | CALEX CONDITIONER | Stephen M Koral, Dmd | 2001-03-27 |
| K001050 | CALCIJECT | Centrix, Inc. | 2000-07-21 |
| K983477 | SUPER SEAL | Phoenix Dental, Inc. | 1998-12-22 |
| K973539 | ROEKO CALCIUM HYDROXIDE POINTS | Roeko USA, Inc. | 1997-10-30 |
| K970113 | ULTRA-BLEND PLUS | Ultradent Products, Inc. | 1997-04-02 |
| K970114 | ULTRACAL XS | Ultradent Products, Inc. | 1997-03-14 |
| K964191 | CALCIUM HYDROXIDE MEDICAMENT | Sybron Dental Specialties, Inc. | 1997-01-22 |
| K961708 | LIFE AND LIFE FAST SET | Sybron Dental Specialties, Inc. | 1996-05-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800071200017 | CleaniCal | MARUCHI | 2023-05-16 |
| 14548161282833 | GC Fuji LINING™ | Gc America Inc. | 2022-08-19 |
| 14548161293600 | GC Fuji LINING™ | Gc America Inc. | 2022-08-19 |
| 14548161294300 | GC Fuji LINING™ | Gc America Inc. | 2022-08-19 |
| 07615208008661 | ApexCal | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-08-18 |
| 10386040009201 | GC Fuji LINING™ | Gc America Inc. | 2022-07-13 |
| 10810000526830 | Parkell® | PARKELL, INC. | 2021-06-18 |
| 10810000528254 | Parkell® | PARKELL, INC. | 2021-06-18 |
| D023P041031 | QUALA | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2019-02-14 |
| D0026238011 | Dycal® Ivory Radiopaque Calcium Hydroxide Composition | DENTSPLY INTERNATIONAL INC. | 2016-09-23 |
| D0026238021 | Dycal® Dentin Radiopaque Calcium Hydroxide Composition | DENTSPLY INTERNATIONAL INC. | 2016-09-23 |
| D661H015000 | Hygenic | COLTENE/WHALEDENT INC | 2016-09-23 |
| D010606065951 | CHEMFIL ROCK | Dentsply De Trey GmbH | 2016-09-20 |
| D010606065941 | CHEMFIL ROCK | Dentsply De Trey GmbH | 2016-09-20 |
| D010606065931 | CHEMFIL ROCK | Dentsply De Trey GmbH | 2016-09-20 |
| D010606065921 | CHEMFIL ROCK | Dentsply De Trey GmbH | 2016-09-20 |
| D010606065911 | CHEMFIL ROCK | Dentsply De Trey GmbH | 2016-09-20 |
| D010606065901 | CHEMFIL ROCK | Dentsply De Trey GmbH | 2016-09-20 |
| D0470000211 | GC Fuji LINING™ | Gc America Inc. | 2016-08-01 |
| D0470000221 | GC Fuji LINING™ | Gc America Inc. | 2016-08-01 |
| D0470001281 | GC Fuji LINING™ | Gc America Inc. | 2016-08-01 |
| D0470018871 | GC Fuji LINING™ | Gc America Inc. | 2016-08-01 |
| D6584325711 | GC Fuji LINING™ | Gc America Inc. | 2016-08-01 |
| D661H015010 | Hygenic | COLTENE/WHALEDENT INC | 2016-07-01 |
| D661H015051 | Hygenic | COLTENE/WHALEDENT INC | 2016-07-01 |
| D661H015061 | Hygenic | COLTENE/WHALEDENT INC | 2016-07-01 |
| D661H015071 | Hygenic | COLTENE/WHALEDENT INC | 2016-07-01 |
| D661H015081 | Hygenic | COLTENE/WHALEDENT INC | 2016-07-01 |
| D661H015091 | Hygenic | COLTENE/WHALEDENT INC | 2016-07-01 |
| D661H015101 | Hygenic | COLTENE/WHALEDENT INC | 2016-07-01 |