Cleared Traditional

CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid

K212563 · Prevest Denpro Limited · Dental
May 2022
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K212563 is an FDA 510(k) clearance for the CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on May 23, 2022, 283 days after receiving the submission on August 13, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K212563 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2021
Decision Date May 23, 2022
Days to Decision 283 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820

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