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510(k) K933542

MESIAL LOOP BAR by Gac Intl., Inc. — Product Code ECO

K933542 is an FDA 510(k) premarket notification submitted by Gac Intl., Inc. for the device "MESIAL LOOP BAR". The FDA issued a decision of Substantially Equivalent on August 5, 1994. The device falls under product code ECO (Spring, 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 5, 1994
Date Received
July 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spring, 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)
  • 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)
  • 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 ECO

  • K943068 — MAGNEFORCE (August 17, 1994)
  • K942492 — ADJUSTABLE BITE CORRECTOR (July 13, 1994)
  • K844234 — ACTIVE VERTICAL CORRECTOR APPLIANCE (January 4, 1985)
  • K843550 — ORTHOMAG MAGNETIC FORCE SYSTEM (December 21, 1984)
  • K843344 — ACTIVE VERTICAL CORRECTOR ACTIVE BITE (December 3, 1984)
  • K770558 — ISODYNE (April 5, 1977)

FDA data resources