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510(k) K932825

MICROARCH GOLD BRACKET by Gac Intl., Inc. — Product Code EJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1994
Date Received
June 9, 1993
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

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  • K932025 — ION-IMPLANTED NEO SENTALLOY (September 13, 1993)
  • K920905 — BIOFORCE WIRE (November 4, 1992)
  • K923029 — ORTHODONTIC STAINLESS STEEL BRACKET (September 28, 1992)
  • K920850 — GAC THUMB-SUCKING CONTROL APPLIANCE (August 24, 1992)
  • K920784 — ORTHODONTIC FACE BOW W/ INNER WIRE (March 20, 1992)
  • K852179 — CERAMIC ORTHODONIT APPLIANCE (August 20, 1985)

Other clearances for product code EJF

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  • 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)
  • K926427 — LARIAT PALATE EXPANDER (January 26, 1994)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)