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510(k) K920850

GAC THUMB-SUCKING CONTROL APPLIANCE by Gac Intl., Inc. — Product Code DZC

K920850 is an FDA 510(k) premarket notification submitted by Gac Intl., Inc. for the device "GAC THUMB-SUCKING CONTROL APPLIANCE". The FDA issued a decision of Substantially Equivalent on August 24, 1992. The device falls under product code DZC (Wire, 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
August 24, 1992
Date Received
February 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code DZC

  • K112640 — HYPERELASTIC WIRE (November 16, 2011)
  • K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (October 5, 1994)
  • K935638 — NITINOL, NITI (May 18, 1994)
  • K935140 — DENTAURUM STEEL LIGATURE WIRES (February 4, 1994)
  • K935142 — DENTAURUM WIRES (January 31, 1994)
  • K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (January 21, 1994)
  • K933374 — NITI COIL SPRINGS (November 19, 1993)
  • K933377 — STAINLESS STEEL ARCHES REPACKER RELABETER (November 16, 1993)
  • K933379 — STAINLESS STEEL ARCHES (November 12, 1993)
  • K933376 — NITI ARCH WIRE ON A SPOOL (November 12, 1993)

FDA data resources