Cleared Traditional

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

K214054 · Tp Orthodontics, Inc. · Dental

Oct 2022

Decision

291d

Days

Class 2

Risk

About This 510(k) Submission

K214054 is an FDA 510(k) clearance for the TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on October 14, 2022, 291 days after receiving the submission on December 27, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number	K214054 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2021
Decision Date	October 14, 2022
Days to Decision	291 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF