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510(k) K214054

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 by Tp Orthodontics, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2022
Date Received
December 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

Other clearances by Tp Orthodontics, Inc.

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  • K111234 — CLICK-IT (May 13, 2011)
  • K952643 — RIGHT-ON ADHESIVE BOUDING SYSTEM (July 11, 1995)
  • K950992 — CERAMAFLEX BRACKET SYSTEM (May 3, 1995)

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