Bsm Bone Substitute Material Kit
by Etex Corp.
510(k) K962548
Bsm Bone Substitute Material Kit is a Class II device made by Etex Corp., cleared under FDA 510(k) K962548 on 5 Aug 1997, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962548 | Date5 Aug 1997 | StatusActive |
Official records
- FDA 510(k) database K962548
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LYC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LYC (Bone Grafting Material, Synthetic).
- TRICOS T RESORBABLE BONE SUBSTITUTE by Baxter Healthcare Corp
- OSTEOGRAF/D-100 HYDROXYLAPATITE by Ceramed Corp.
- MODIFICATION TO UNIGRAFT by UNICARE BIOMEDICAL, INC.
- OSTEOGRAF/D-300 by Dentsply International
- BIO-INTERFACES, INC, . BII-PLAST by Bio-Interfaces, Inc.
- OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40 by Coors Biomedical Co.
- PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT by Carbomedics, Inc.
- Cytrans Granules by Gc America Inc.
- DENTORIDGE(TM) HYDROXYYLAPATITE by Norian Corp.
- BioMend® Extend™ Absorbable Collagen Membrane 0140 by Integra Lifesciences Corp.