Bio-Interfaces, Inc.
United StatesFDA applicant, unverified
- Devices
- 17
What Bio-Interfaces, Inc. makes
Bio-Interfaces, Inc. manufactures bone graft materials, including hydroxyapatite (HA) particles in various formulations (e.g., 4060 HA, 1840 HA, BIO-APATITE 6140) and bioceramic substitutes like porous HA and calcium phosphate particles for resorbable grafting. The company also produces bone graft delivery syringes and endosseous dental implant systems, including canal wall prostheses for dental reconstruction.
The portfolio includes Class I and Class II devices, with submissions recorded under the FDA’s 510(k) pathway. Products are listed in the U.S. regulatory registry, reflecting their authorised status under applicable medical device regulations.
Catalogue
Search and filter all 17 devicesFrequently asked questions
How many devices does Bio-Interfaces, Inc. have in the registry?
The registry currently lists 17 devices for Bio-Interfaces, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Interfaces, Inc.'s devices?
Among its 17 most recently registered devices, Bio-Interfaces, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Bio-Interfaces, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Bio-Interfaces, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Interfaces, Inc. in the registry?
The most recently registered devices listed for Bio-Interfaces, Inc. include BIO-INTERFACES, INC, . BII-PLAST, BONE GRAFT DELIVERY SYRINGES, 4060 HA PARTICLES and 1840 HA PARTICLES.