Simpact, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Simpact, LLC makes
Simpact, LLC manufactures dental implant systems, including the SIMPACT IMPLANT SYSTEM and the SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM, designed for osseointegrated tooth replacement in oral and maxillofacial applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Simpact Implant System Ref K081226
Regimes: 510(k) Registry: 510(k)Simpact Endosseous Dental Implant System Ref K083141
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Simpact, LLC have in the registry?
The registry currently lists 2 devices for Simpact, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Simpact, LLC's devices?
Among its 2 most recently registered devices, Simpact, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Simpact, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Simpact, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Simpact, LLC in the registry?
The most recently registered devices listed for Simpact, LLC include SIMPACT IMPLANT SYSTEM and SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM.