EJK · Liner, Cavity, Calcium Hydroxide
Dental · 21 CFR 872.3250 · Class 2
Overview
| Product Code | EJK |
|---|---|
| Device Name | Liner, Cavity, Calcium Hydroxide |
| Regulation | 21 CFR 872.3250 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 77)
Showing 20 most recent of 77 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253248 | Bright Cavity Liner | Dmp Dental Industry S.A. | Jan 13, 2026 | SESE |
| K230270 | 3M VitCal Liner/Base | 3M Espe Dental Products | Feb 6, 2023 | SESE |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | May 13, 2022 | SESE |
| K201799 | CleaniCal | Maruchi | Feb 12, 2021 | SESE |
| K202413 | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | Nov 20, 2020 | SESE |
| K191103 | Parkell Desensitizer Gel | Parkell, Inc. | Nov 22, 2019 | SESE |
| K180344 | TheraCal DC | Bisco, Inc. | Apr 5, 2018 | SESE |
| K143292 | TheraCal DC | Bisco, Inc. | Aug 4, 2015 | SESE |
| K150559 | Life Fast Set, Life Regular Set | Sybron Dental Specialties | Jun 19, 2015 | SESE |
| K141047 | LC CALCIUMHYDROXIDE LINER | S&C Polymer Silicon- Und Composite Spezialitaeten | Apr 14, 2015 | SESE |
| K134022 | BASE IT | Spident Co., Ltd. | Jun 11, 2014 | SESE |
| K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | Aug 27, 2013 | SESE |
| K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | Dec 11, 2012 | SESE |
| K120003 | NUCAL | Pulpdent Corporation | Apr 5, 2012 | SESE |
| K113711 | LIME-LITE II | Pulpdent Corporation | Mar 5, 2012 | SESE |
| K111668 | CAVIOS CAVITY LINER | Neodental Chemical Products Co., Ltd. | Aug 19, 2011 | SESE |
| K063237 | THERACAL LC | Bisco, Inc. | Dec 8, 2006 | SESE |
| K060365 | APEXCAL | Ivoclar Vivadent, Inc. | Apr 17, 2006 | SESE |
| K033521 | BISBLOCK | Bisco, Inc. | Jan 16, 2004 | SESE |
| K022025 | MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT | Milton Hodosh, M.D. | Aug 15, 2002 | SESE |
Top Applicants
- Ultradent Products, Inc. — 5 clearances
- Voco GmbH — 4 clearances
- Sybron Dental Specialties, Inc. — 4 clearances
- Dentsply Intl. — 4 clearances
- Centrix, Inc. — 4 clearances
