Branemark Integration AB
SwedenFDA 510(k) applicant, unverified
- Devices
- 3
What Branemark Integration AB makes
Branemark Integration AB manufactures dental implants and related accessories, including endosseous implants designed for osseointegration in oral and maxillofacial applications. Their portfolio includes the Branemark Integration Dental Implant system and BioHelix implants, which are intended for permanent tooth replacement and bone-anchored prosthetics.
These devices are classified as Class II under regulatory frameworks, with the majority authorised via the FDA’s 510(k) pathway. The company’s products are listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.
Catalogue
- 510(k) 510(k)
Branemark Integration Biohelix Implants Ref K090005
510(k) 510(k)Endosseous Implant Ref K021355
510(k) 510(k)
Frequently asked questions
How many devices does Branemark Integration AB have in the registry?
The registry currently lists 3 devices for Branemark Integration AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Branemark Integration AB's devices?
Among its 3 most recently registered devices, Branemark Integration AB has devices listed in FDA 510(k) (3 devices).
What risk classes do Branemark Integration AB's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Branemark Integration AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Branemark Integration AB in the registry?
The most recently registered devices listed for Branemark Integration AB include BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES, BRANEMARK INTEGRATION BIOHELIX IMPLANTS and ENDOSSEOUS IMPLANT.