Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3250](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3250) → EJK — Liner, Cavity, Calcium Hydroxide # EJK · Liner, Cavity, Calcium Hydroxide _Dental · 21 CFR 872.3250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK ## Overview - **Product Code:** EJK - **Device Name:** Liner, Cavity, Calcium Hydroxide - **Regulation:** [21 CFR 872.3250](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3250) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K253248.md) | Bright Cavity Liner | Dmp Dental Industry S.A. | Jan 13, 2026 | SESE | | [K230270](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K230270.md) | 3M™ VitCal Liner/Base | 3M Espe Dental Products | Feb 6, 2023 | SESE | | [K212475](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K212475.md) | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | May 13, 2022 | SESE | | [K201799](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K201799.md) | CleaniCal | Maruchi | Feb 12, 2021 | SESE | | [K202413](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K202413.md) | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | Nov 20, 2020 | SESE | | [K191103](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K191103.md) | Parkell Desensitizer Gel | Parkell, Inc. | Nov 22, 2019 | SESE | | [K180344](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K180344.md) | TheraCal DC | Bisco, Inc. | Apr 5, 2018 | SESE | | [K143292](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K143292.md) | TheraCal DC | Bisco, Inc. | Aug 4, 2015 | SESE | | [K150559](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K150559.md) | Life Fast Set, Life Regular Set | Sybron Dental Specialties | Jun 19, 2015 | SESE | | [K141047](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K141047.md) | LC CALCIUMHYDROXIDE LINER | S&C Polymer Silicon- Und Composite Spezialitaeten | Apr 14, 2015 | SESE | | [K134022](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K134022.md) | BASE IT | Spident Co., Ltd. | Jun 11, 2014 | SESE | | [K131068](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K131068.md) | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | Aug 27, 2013 | SESE | | [K122421](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K122421.md) | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | Dec 11, 2012 | SESE | | [K120003](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K120003.md) | NUCAL | Pulpdent Corporation | Apr 5, 2012 | SESE | | [K113711](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K113711.md) | LIME-LITE II | Pulpdent Corporation | Mar 5, 2012 | SESE | | [K111668](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K111668.md) | CAVIOS CAVITY LINER | Neodental Chemical Products Co., Ltd. | Aug 19, 2011 | SESE | | [K063237](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K063237.md) | THERACAL LC | Bisco, Inc. | Dec 8, 2006 | SESE | | [K060365](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K060365.md) | APEXCAL | Ivoclar Vivadent, Inc. | Apr 17, 2006 | SESE | | [K033521](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K033521.md) | BISBLOCK | Bisco, Inc. | Jan 16, 2004 | SESE | | [K022025](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK/K022025.md) | MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT | Milton Hodosh, M.D. | Aug 15, 2002 | SESE | ## Top Applicants - Ultradent Products, Inc. — 5 clearances - Bisco, Inc. — 4 clearances - Centrix, Inc. — 4 clearances - Dentsply Intl. — 4 clearances - Sybron Dental Specialties, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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