Cleared Traditional

3M? Transbond? Orthodontic Adhesive

K234043 · 3M Unitek Orthodontic Products · Dental

Dec 2023

Decision

Days

Class 2

Risk

About This 510(k) Submission

K234043 is an FDA 510(k) clearance for the 3M? Transbond? Orthodontic Adhesive, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by 3M Unitek Orthodontic Products (Monrovia, US). The FDA issued a Cleared decision on December 22, 2023, 1 days after receiving the submission on December 21, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number	K234043 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2023
Decision Date	December 22, 2023
Days to Decision	1 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF