Macrochem Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Macrochem Corp. makes
Macrochem Corp. manufactures dental adhesive and restorative materials, including visible-light-cured antimicrobial dental kits, dual-cure and light-cure ceramic veneer cements, and pit-and-fissure sealants for pediatric dental applications.
The company’s portfolio consists of Class II medical devices authorised via the FDA’s 510(k) pathway. These products are listed under the US Food and Drug Administration’s regulatory framework.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Fluorever(R) Dual Cure Ceramic Veneer Cement Ref K890623
Regimes: 510(k) Registry: 510(k)Fluorever(R) Light Cure Ceramic Veneer Cement Ref K890608
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Macrochem Corp. have in the registry?
The registry currently lists 5 devices for Macrochem Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Macrochem Corp.'s devices?
Among its 5 most recently registered devices, Macrochem Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Macrochem Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Macrochem Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Macrochem Corp. in the registry?
The most recently registered devices listed for Macrochem Corp. include REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT, ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT, FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT and FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT.