Cleared Traditional

C&B Ceramic; C&B Permanent; C&B Interim

K233273 · Prevest Denpro Limited · Dental
Nov 2024
Decision
425d
Days
Class 2
Risk

About This 510(k) Submission

K233273 is an FDA 510(k) clearance for the C&B Ceramic; C&B Permanent; C&B Interim, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Prevest Denpro Limited (Bari Brahmana, IN). The FDA issued a Cleared decision on November 27, 2024, 425 days after receiving the submission on September 29, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K233273 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date November 27, 2024
Days to Decision 425 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690

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