Unicep
Country not established
- Devices
- 9
What Unicep makes
Unicep manufactures dental adhesives and restorative materials, including enamel and dentin conditioners, porcelain and enamel etchants, pit-and-fissure sealants, and bonding agents like silane and potassium oxylate. Their portfolio also includes antimicrobial preparations such as chlorhexidine-based solutions and a ready-to-use cavity preparation system for dental procedures.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Unicep operates from the United States.
Catalogue
Microdose Dentin Conditioner Ref K925162
Regimes: 510(k) Registry: 510(k)Microdose Rc-Ez Ref K924825
Regimes: 510(k) Registry: 510(k)Microdose Total Etchant Ref K924826
Regimes: 510(k) Registry: 510(k)Microdose Porcelain Etchant Ref K924821
Regimes: 510(k) Registry: 510(k)Microdose Pit And Fissure Sealant-Clear Or White Ref K924824
Regimes: 510(k) Registry: 510(k)Microdose Enamel Etchant Ref K924822
Regimes: 510(k) Registry: 510(k)Micodose Chlorhexiprep Ref K925163
Regimes: 510(k) Registry: 510(k)Microdose Potassium Oxylate Ref K924827
Regimes: 510(k) Registry: 510(k)Microdose Silane Ref K924823
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unicep have in the registry?
The registry currently lists 9 devices for Unicep. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unicep's devices?
Among its 9 most recently registered devices, Unicep has devices listed in FDA 510(k) (9 devices).
What risk classes do Unicep's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Unicep's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unicep in the registry?
The most recently registered devices listed for Unicep include MICRODOSE DENTIN CONDITIONER, MICRODOSE RC-EZ, MICRODOSE TOTAL ETCHANT and MICRODOSE PORCELAIN ETCHANT.