Medical Device Manufacturer · US , Woburn , MA

Macrochem Corp. - FDA 510(k) Cleared Devices

5 submissions · 4 cleared · Since 1986

5

Total

4

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Apr 17, 1989

FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT

Cleared Apr 17, 1989

FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT

Cleared Mar 29, 1989

FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS

Cleared Aug 19, 1988

ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT

Cleared May 21, 1986

REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT