Medical Device Manufacturer · US , Mchenry , IL

The Hygenic Corp. - FDA 510(k) Cleared Devices

16 submissions · 15 cleared · Since 1979

16

Total

15

Cleared

0

Denied

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

14 devices

1-14 of 14

Cleared Jan 26, 1996

Cleared May 27, 1993

ENDO-ICE-PULP TESTER-THERMAL

Cleared Jul 25, 1991

GATES GLIDDEN DRILLS

Cleared Mar 05, 1991

SOLID CORE GUTTA PERCHA CARRIER

Cleared May 15, 1990

NOVUS BONDING AGENT

Cleared Apr 16, 1990

Cleared Jan 10, 1990

DENTAL ENDODONTIC CEMENT (MODIFICATION)

Cleared Aug 23, 1988

Cleared Oct 27, 1987

Cleared Jun 11, 1987

Cleared Mar 10, 1986

INLAY WAX REGULAR

Cleared Mar 04, 1986

Cleared Mar 04, 1986

PREMIUM FLEXI-TOUGH

Cleared Apr 16, 1985

ULTRAFIL-LT (GUTTA PERCHA)