Medical Device Manufacturer · US , Mchenry , IL

Ormco Corp. - FDA 510(k) Cleared Devices

40 submissions · 39 cleared · Since 1978

40

Total

39

Cleared

0

Denied

40 devices

26-40 of 40

Cleared Nov 20, 1991

KLEER(TM) ORTHODONTIC BRACKET

Cleared Dec 27, 1990

THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM

Cleared Sep 06, 1990

HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL

Cleared Sep 06, 1990

HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP

Cleared Apr 02, 1990

Cleared Mar 08, 1990

Cleared Sep 15, 1989

LUMINA ORTHODONTIC BRACKET

Cleared Sep 15, 1989

Cleared Jun 12, 1989

GEM II ORTHODONTIC BRACKET

Cleared Apr 25, 1989

FRS LITE FLUORIDE RELEASING SEALANT

Cleared Feb 19, 1987

GEM ORTHODONTIC BRACKET

Cleared Jan 21, 1987

CHALLENGE ORTHODONTIC BONDING ADHESIVE

Cleared Jul 11, 1986

SENTRY BREAKWAY NECK STRAP

Cleared Aug 29, 1985

ORMCO TRANSMANDIBULAR IMPLANT

Cleared Mar 15, 1978

BRACKET, METAL REINFORCED PLASTIC