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510(k) K904128

PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER by American Orthodontics — Product Code KMY

K904128 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER". The FDA issued a decision of Substantially Equivalent on November 9, 1990. The device falls under product code KMY (Positioner, Tooth, Preformed), a Class I device regulated under 21 CFR 872.5525. American Orthodontics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1990
Date Received
September 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Positioner, Tooth, Preformed
Device Class
Class I
Regulation Number
872.5525
Review Panel
DE
Submission Type

Other clearances by American Orthodontics

  • K261840 — BracePaste Prime Plus (June 3, 2026)
  • K242537 — BracePaste Fluoride Sealant (August 27, 2024)
  • K232011 — Cleo (July 7, 2023)
  • K202276 — BracePaste Band and Build LC (August 14, 2020)
  • K181910 — BracePaste MTP Light Cure Primer (October 15, 2018)
  • K172953 — Acid Etchant (February 6, 2018)
  • K160782 — BracePaste Adhesive (October 14, 2016)
  • K143117 — Wire Sterilization Package with Indicators (October 29, 2015)
  • K122753 — EMPOWER CLEAR (December 14, 2012)
  • K080749 — RADIANCE (August 4, 2008)

Other clearances for product code KMY

  • K931615 — NITE-GUIDE (April 14, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K924351 — GLENROE ELASTIBITE STIMULATOR (January 6, 1994)
  • K925064 — RELAX-O-GUARD (September 13, 1993)
  • K924975 — THE ORTHOTRAINER (July 8, 1993)
  • K924974 — THE TMJ APPLIANCE (June 23, 1993)
  • K891328 — PREFORMED TEMPLATE FOR TOOTH POSITIONER (March 31, 1989)
  • K833455 — REMOLDABLE CRANIOMANDIBULAR APPLIANCE (January 10, 1984)
  • K831793 — AQUALIZER MOUTHPIECE (August 12, 1983)
  • K821458 — DYNAMIC FUNTIONAL POSITIONER (June 9, 1982)

FDA data resources