510(k) K223365

RODIN Palette Naturalizing Kit by Belport Company, Inc., Gingi-Pak — Product Code EBD

K223365 is an FDA 510(k) premarket notification submitted by Belport Company, Inc., Gingi-Pak for the device "RODIN Palette Naturalizing Kit". The FDA issued a decision of Substantially Equivalent on March 27, 2023. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Belport Company, Inc., Gingi-Pak has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2023
Date Received
November 3, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type