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510(k) K201940

Braces on Demand Bracket by Braces on Demand, Inc. — Product Code DYW

K201940 is an FDA 510(k) premarket notification submitted by Braces on Demand, Inc. for the device "Braces on Demand Bracket". The FDA issued a decision of Substantially Equivalent on December 3, 2020. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2020
Date Received
July 13, 2020
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 for product code DYW

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  • K251196 — Composite Orthodontic Brackets and Buttons (April 21, 2025)
  • 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)

FDA data resources