Home / 510(k) Clearances / K101676

510(k) K101676

CLEARARCH by Ormco Corp. — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2010
Date Received
June 15, 2010
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 Ormco Corp.

  • K141611 — LYTHOS DIGITAL IMPRESSION SYSTEM (December 5, 2014)
  • K123118 — INSIGNIA DIGICAST (March 26, 2013)
  • K123416 — INSIGNIA WITH ITERO (March 13, 2013)
  • K122065 — DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE (February 8, 2013)
  • K121524 — INSIGNIA (August 9, 2012)
  • K112640 — HYPERELASTIC WIRE (November 16, 2011)
  • K081900 — TEMPORARY TOOTH REPLACEMENT (October 24, 2008)
  • K081415 — DAMON 4CLEAR (September 24, 2008)
  • K062856 — TF ROTARY NICKEL TITANIUM FILE (December 13, 2006)
  • K061481 — GRENGLOO (July 6, 2006)

Other clearances for product code DYW

  • K252760 — Carriere® Motion Pro® Clear Bite Corrector (November 27, 2025)
  • 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)