Medical Device Manufacturer · US , Mchenry , IL

Unitek Corp. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1980

23

Total

23

Cleared

0

Denied

FDA 510(k) Regulatory Record - Unitek Corp. Dental ✕

23 devices

1-12 of 23

Cleared Nov 29, 1994

METAL-LINED TRANSCEND CERAMIC BRACKET

Cleared Apr 28, 1994

Cleared Mar 07, 1994

Cleared Jun 24, 1993

Cleared Nov 25, 1992

TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS

Cleared Nov 23, 1992

DEBRACKETING INSTRUMENT

Cleared Oct 30, 1992

GERMAN MINI DYNALOCK

Cleared May 29, 1991

ADHESIVE PRECOATED BRACKETS

Cleared Mar 29, 1991

NONSTAINING ALASTIKS

Cleared Mar 09, 1989

Cleared Apr 07, 1988

ORTHOLUX VISIBLE LIGHT CURING UNIT

Cleared Mar 31, 1988

TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE