Medical Device Manufacturer · US , Chicago , IL

Prime Dental Manufacturing, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2000

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Prime Dental Manufacturing, Inc. Dental ✕

9 devices

1-9 of 9

Cleared Jan 23, 2012

PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT

Cleared Nov 07, 2002

PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL

Cleared Jul 19, 2002

LIGHT CURE DENTAL DAM

Cleared Feb 19, 2002

PRIME-DENT HEMA DESENSITIZER

Cleared Nov 05, 2001

PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT

Cleared Nov 01, 2001

PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT

Cleared Oct 24, 2001

PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

Cleared May 30, 2000

PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL

Cleared Jan 31, 2000

PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL