Medical Device Manufacturer · US , Mchenry , IL

Parkell, Inc. - FDA 510(k) Cleared Devices

53 submissions · 53 cleared · Since 1976

53

Total

53

Cleared

0

Denied

53 devices

26-50 of 53

Cleared Feb 07, 2000

RESIN TOOTH BONDING AGENT

Cleared May 21, 1999

Cleared May 17, 1999

Cleared Dec 21, 1998

MODEL MS-1 HANDPIECE

Cleared Sep 02, 1998

MODEL MS-2 HANDPIECE

Cleared Mar 16, 1998

Cleared Mar 10, 1998

Cleared Dec 04, 1997

Cleared Nov 06, 1997

Cleared Aug 29, 1997

Cleared Apr 11, 1997

HYBRID RESIN COMPOSITE

Cleared Sep 06, 1996

TRI-PHASIX CHROMATIC ALGINATE

Cleared Mar 22, 1996

AMALGAMIBOND PLUS

Cleared Feb 26, 1996

C & B METABOND (MODIFICATION)

Cleared Jun 20, 1995

Cleared Jun 20, 1995

Cleared Jun 09, 1995

Cleared Jun 06, 1995

SENSIMATIC 500SE

Cleared May 09, 1995

Cleared Apr 20, 1995

Cleared Apr 10, 1995

C&B-METABOND RADIOPAQUE POWDER

Cleared Apr 04, 1995

LE CLEAN MACHINE

Cleared Apr 04, 1995

Cleared Jul 06, 1994

Cleared Oct 20, 1993

INTRA-ORAL IRRIGATOR