Not currently registered with FDA under this name
Macrochem Corp.
Billerica, MA, United States. Named as applicant on 5 dental 510(k) clearances between 1986 and 1989. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 51986–1989
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1980–2026
510(k) clearances
Clearances on which FDA names Macrochem Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Apr 1989 | K890623 | FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT | EMA Dental Cement |
| 17 Apr 1989 | K890608 | FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT | EMA Dental Cement |
| 29 Mar 1989 | K890494 | FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS | EBC Pit and Fissure Sealant and Conditioner |
| 19 Aug 1988 | K880562 | ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 21 May 1986 | K861546 | REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT | EBF Resin Tooth Shade Material |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.