Cleared Traditional

Rainbow 360

K222830 · Kerr Corporation · Dental
Jan 2023
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K222830 is an FDA 510(k) clearance for the Rainbow 360, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Kerr Corporation (Pomona, US). The FDA issued a Cleared decision on January 12, 2023, 115 days after receiving the submission on September 19, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K222830 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2022
Decision Date January 12, 2023
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200