Macrochem Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Macrochem Corp. - FDA 510(k) Cleared Devices
5
Total
4
Cleared
0
Denied
Macrochem Corp. has 4 FDA 510(k) cleared medical devices. Based in Woburn, US.
Historical record: 4 cleared submissions from 1986 to 1989. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Macrochem Corp. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Macrochem Corp.
5 devices
Cleared
Apr 17, 1989
FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT
Dental
70d
Cleared
Apr 17, 1989
FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT
Dental
69d
Cleared
Mar 29, 1989
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
Dental
57d
Cleared
Aug 19, 1988
ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT
Dental
190d
Cleared
May 21, 1986
REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT
Dental
26d