Cleared Traditional

RIGHT-ON ADHESIVE BOUDING SYSTEM

K952643 · Tp Orthodontics, Inc. · Dental
Jul 1995
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K952643 is an FDA 510(k) clearance for the RIGHT-ON ADHESIVE BOUDING SYSTEM, 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 July 11, 1995, 32 days after receiving the submission on June 9, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K952643 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1995
Decision Date July 11, 1995
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DYH — Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3750

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