Cleared Traditional

Premier's MultiMatch Universal Chameleon Restorative Composite

K223632 · Premier Dental Products Company · Dental
Dec 2022
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K223632 is an FDA 510(k) clearance for the Premier's MultiMatch Universal Chameleon Restorative Composite, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Premier Dental Products Company (Plymouth Meeting, US). The FDA issued a Cleared decision on December 6, 2022, 1 days after receiving the submission on December 5, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K223632 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2022
Decision Date December 06, 2022
Days to Decision 1 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