Medical Device Manufacturer · US , Farmingdale , NY

Parkell - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1988

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Parkell Dental ✕

8 devices

1-8 of 8

Cleared Oct 06, 1992

Cleared Mar 15, 1991

MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL

Cleared Apr 12, 1990

Cleared Feb 22, 1990

PRIMER-P ADHESIVE AGENT

Cleared Dec 21, 1989

Cleared Jun 07, 1989

ABRAKADABRA - DENTAL ADHESIVE SYSTEM

Cleared Feb 13, 1989

PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER

Cleared Jul 15, 1988