Cleared Traditional

RODIN Palette Naturalizing Kit

K223365 · Belport Company, Inc., Gingi-Pak · Dental

Mar 2023

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K223365 is an FDA 510(k) clearance for the RODIN Palette Naturalizing Kit, a Coating, Filling Material, Resin (Class II — Special Controls, product code EBD), submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on March 27, 2023, 144 days after receiving the submission on November 3, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3310.

Submission Details

510(k) Number	K223365 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2022
Decision Date	March 27, 2023
Days to Decision	144 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement