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510(k) K925012

PLASTIC CHAIN by American Orthodontics — Product Code EJF

K925012 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "PLASTIC CHAIN". The FDA issued a decision of Substantially Equivalent on September 13, 1993. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. American Orthodontics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1993
Date Received
October 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
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 EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K923372 — MEMORY WIRE (April 22, 1994)
  • K933080 — ORTHOTECH DURA-GOLD BARCKETS (March 23, 1994)
  • K935139 — FASCINATION CERAMIC BRACKET (February 4, 1994)
  • K936244 — REGENCY BRACKET (February 2, 1994)
  • K934881 — REFLECTIONS (February 1, 1994)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources