Right-On Adhesive Bouding System

FDA 510(k) K952643 · Tp Orthodontics, Inc.

Substantially Equivalent

510(k) numberK952643

Submission

Device name
Right-On Adhesive Bouding System
Applicant
Tp Orthodontics, Inc.
La Porte, IN, US
Received
June 9, 1995
Decision date
July 11, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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More from Dentscare Ltda

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K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…DYH · Traditional 10/14/2022SE
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K111234Click-ItNJM · Traditional 05/13/2011SE
K950992Ceramaflex Bracket SystemNJM · Traditional 05/03/1995SE

Questions and answers

When was Right-On Adhesive Bouding System cleared by the FDA?

Right-On Adhesive Bouding System (K952643) received a 510(k) decision of Substantially Equivalent on July 11, 1995, 32 days after the submission was received.

What is the product code of K952643?

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