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

FDA 510(k) K214054 · Tp Orthodontics, Inc.

Substantially Equivalent

510(k) numberK214054

Submission

Device name
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
Applicant
Tp Orthodontics, Inc.
La Porte, IN, US
Received
December 27, 2021
Decision date
October 14, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DYH – Adhesive, Bracket And Tooth Conditioner, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3750
Specialty
Dental

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K242537BracePaste Fluoride SealantDYH · Traditional American Orthodontics Corp.08/27/2024SE
K2340433M™ Transbond™ Orthodontic AdhesiveDYH · Traditional 3M Unitek Orthodontic Products12/22/2023SE
K231817AlignerFlow LCDYH · Traditional Voco GmbH12/01/2023SE
K210115FiteBac CC OrthoSealDYH · Traditional Largent Health, LLC07/29/2021SE
K202276BracePaste Band and Build LCDYH · Traditional American Orthodontics08/14/2020SE
K192682Orthocem, Ortho BiteDYH · Traditional Dentscare Ltda08/14/2020SE
K193388GlassLok Kits, GlassLok Powder, GlassLok LiquidDYH · Traditional Reliance Orthodontic Products, Inc.04/27/2020SE

More from Reliance Orthodontic Products, Inc.

510(k)DeviceDecision
K193385TP Orthodontics Clear Aligner SystemNXC · Traditional 11/12/2020SE
K111234Click-ItNJM · Traditional 05/13/2011SE
K952643Right-On Adhesive Bouding SystemDYH · Traditional 07/11/1995SE
K950992Ceramaflex Bracket SystemNJM · Traditional 05/03/1995SE

Questions and answers

When was TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 cleared by the FDA?

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (K214054) received a 510(k) decision of Substantially Equivalent on October 14, 2022, 291 days after the submission was received.

What is the product code of K214054?

The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.