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510(k) K252760

Carriere® Motion Pro® Clear Bite Corrector by Ortho Organizers, Inc. — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2025
Date Received
August 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

Other clearances by Ortho Organizers, Inc.

  • K173440 — Carriere SLX 3D Clear (March 8, 2018)
  • K160720 — Carriere Motion Clear Class II (November 28, 2016)
  • K110335 — CERAMIC BRACKETS (May 19, 2011)
  • K061266 — ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR (July 31, 2006)
  • K923218 — NITANIUM PALATAL EXPANDER (September 13, 1993)
  • K931980 — STAINLESS STEEL ORTHODONTIC PRODUCTS (September 1, 1993)
  • K931663 — NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL (July 8, 1993)

Other clearances for product code DYW

  • K251196 — Composite Orthodontic Brackets and Buttons (April 21, 2025)
  • K201940 — Braces on Demand Bracket (December 3, 2020)
  • K182338 — Blue Sky Bio Computerized Orthodontic Bracket System (November 9, 2018)
  • K180718 — ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES (October 30, 2018)
  • K160720 — Carriere Motion Clear Class II (November 28, 2016)
  • K150830 — CompleClear Plastic Orthodontic Bracket and Wire Appliance (August 26, 2016)
  • K150702 — Exceed Tx (March 24, 2016)
  • K140807 — COMPOSITE ORTHODONTIC BRACKETS (November 12, 2014)
  • K123118 — INSIGNIA DIGICAST (March 26, 2013)
  • K123416 — INSIGNIA WITH ITERO (March 13, 2013)