Home / 510(k) Clearances / K110796

510(k) K110796

SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE by Biomers Products, LLC — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2011
Date Received
March 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Biomers Products, LLC

  • K101481 — BIOMERS TRANSLUCENT ORTHODONTIC BRACKET (June 23, 2010)

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)