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510(k) K932920

GLENROE PLASTIC BRACKET by Glenroe Technologies — Product Code DYW

K932920 is an FDA 510(k) premarket notification submitted by Glenroe Technologies for the device "GLENROE PLASTIC BRACKET". The FDA issued a decision of Substantially Equivalent on August 24, 1993. The device falls under product code DYW (Bracket, Plastic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Glenroe Technologies has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1993
Date Received
June 15, 1993
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 Glenroe Technologies

  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K945535 — GLENROE ORTHO-SIL (January 27, 1995)
  • K924351 — GLENROE ELASTIBITE STIMULATOR (January 6, 1994)
  • K931462 — GLENROE CHAIN (July 22, 1993)
  • K924140 — TUFF TIES (April 27, 1993)
  • K924139 — GLENROE ORTHO SEPS (April 8, 1993)
  • K924211 — EJECTOR (March 31, 1993)
  • K924993 — GLENROE BAND SEATING CONTOURING INSTRUMENT (November 25, 1992)

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)

FDA data resources