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510(k) K150702

Exceed Tx by Great Lakes Orthodontics, Ltd. — Product Code DYW

K150702 is an FDA 510(k) premarket notification submitted by Great Lakes Orthodontics, Ltd. for the device "Exceed Tx". The FDA issued a decision of Substantially Equivalent on March 24, 2016. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Great Lakes Orthodontics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2016
Date Received
March 18, 2015
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 Great Lakes Orthodontics, Ltd.

  • K172765 — Smart Moves Complete (June 1, 2018)
  • K083479 — BIOCRYL X (February 27, 2009)
  • K041718 — KELES FACEMASK (October 15, 2004)
  • K040881 — METACRYL (May 25, 2004)
  • K033632 — VARIFLEX (January 21, 2004)
  • K922818 — SNORE-NO-MORE (February 9, 1994)
  • K925275 — SOFT DENTURE RELINE MATERIAL ELASTOLINE (January 11, 1993)
  • K870908 — STEADY RESIN (March 19, 1987)
  • K861424 — ADAPTABLE CLASS III MASK (May 29, 1986)
  • K840805 — ORAL SAFE (March 30, 1984)

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)
  • K140807 — COMPOSITE ORTHODONTIC BRACKETS (November 12, 2014)
  • K123118 — INSIGNIA DIGICAST (March 26, 2013)
  • K123416 — INSIGNIA WITH ITERO (March 13, 2013)

FDA data resources