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510(k) K932025

ION-IMPLANTED NEO SENTALLOY by Gac Intl., Inc. — Product Code EJF

K932025 is an FDA 510(k) premarket notification submitted by Gac Intl., Inc. for the device "ION-IMPLANTED NEO SENTALLOY". 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. Gac Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1993
Date Received
April 26, 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

Other clearances by Gac Intl., Inc.

  • K981036 — SMARTBOND (April 5, 1999)
  • K942826 — ORTHODONITC METAL REINFORCED PLASTIC BRACKET (December 14, 1994)
  • K933542 — MESIAL LOOP BAR (August 5, 1994)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K932319 — ORTHODONTIC ELASTOMER (September 20, 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

  • 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