Silicon-Und Composite Spezialitaten GmbH
GermanyFDA applicant, unverified
- Devices
- 4
What Silicon-Und Composite Spezialitaten GmbH makes
Silicon-Und Composite Spezialitaten GmbH manufactures dental devices for cavity preparation and restoration, including a rotary cutting instrument (PROV-KB), priming agents for dental adhesives (MULTI-PRIME and MONO-PRIME), an etching gel for tooth surface treatment, and a tray system for handling dental materials (TRAY-LINK).
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Prov-Kb Ref K960938
Regimes: 510(k) Registry: 510(k)Multi-Prime Aka/Mono-Prime Ref K953476
Regimes: 510(k) Registry: 510(k)Etching Gel Ref K991450
Regimes: 510(k) Registry: 510(k)Tray-Link Ref K992001
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Silicon-Und Composite Spezialitaten GmbH have in the registry?
The registry currently lists 4 devices for Silicon-Und Composite Spezialitaten GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Silicon-Und Composite Spezialitaten GmbH's devices?
Among its 4 most recently registered devices, Silicon-Und Composite Spezialitaten GmbH has devices listed in FDA 510(k) (4 devices).
What risk classes do Silicon-Und Composite Spezialitaten GmbH's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Silicon-Und Composite Spezialitaten GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Silicon-Und Composite Spezialitaten GmbH in the registry?
The most recently registered devices listed for Silicon-Und Composite Spezialitaten GmbH include PROV-KB, MULTI-PRIME AKA/MONO-PRIME, ETCHING GEL and TRAY-LINK.