Medical Device Manufacturer · US , Central Islip , NY

Gac Intl., Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1977

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gac Intl., Inc. Dental ✕

13 devices

1-12 of 13

Cleared Apr 05, 1999

Cleared Dec 14, 1994

ORTHODONITC METAL REINFORCED PLASTIC BRACKET

Cleared Aug 05, 1994

MESIAL LOOP BAR

Cleared May 09, 1994

MICROARCH GOLD BRACKET

Cleared Sep 20, 1993

ORTHODONTIC ELASTOMER

Cleared Sep 13, 1993

ION-IMPLANTED NEO SENTALLOY

Cleared Nov 04, 1992

Cleared Sep 28, 1992

ORTHODONTIC STAINLESS STEEL BRACKET

Cleared Aug 24, 1992

GAC THUMB-SUCKING CONTROL APPLIANCE

Cleared Mar 20, 1992

ORTHODONTIC FACE BOW W/ INNER WIRE

Cleared Aug 20, 1985

CERAMIC ORTHODONIT APPLIANCE

Cleared May 09, 1985

SENTINOL -ORTHODONTIC ARCH WIRE