Cleared Traditional

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

K212475 · Prevest Denpro Limited · Dental
May 2022
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K212475 is an FDA 510(k) clearance for the Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra), a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on May 13, 2022, 280 days after receiving the submission on August 6, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K212475 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2021
Decision Date May 13, 2022
Days to Decision 280 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250

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