Ossix Bone
510(k) K163714
Ossix Bone is a Class II device made by Datum Dental Ltd, cleared under FDA 510(k) K163714 on 18 Jul 2017, 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 | NumberK163714 | Date18 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K163714
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NPM
- FDA applicant
- Datum Dental, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K163714
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| OSSIX™ Bone 0.125 cc | OXB0125 / 0.125 cc | 07290015477215 | Depth 5 mm; Length 5 mm; Height 5 mm | On the market |
| OSSIX™ Bone 0.250 cc | OXB0250 / 0.250 cc | 07290015477222 | Height 5 mm; Length 10 mm; Depth 5 mm | On the market |
| OSSIX™ Bone 0.500 cc | OXB0500 / 0.500 cc | 07290015477253 | Height 5 mm; Length 10 mm; Depth 10 mm | On the market |
Similar devices
Other devices filed under FDA product code NPM (Bone Grafting Material, Animal Source).
- S1-XB-C100 by Medpark Co., Ltd.
- Geistlich Bio-Oss® by Geistlich Pharma AG
- MatrixOss Granules PMC2020 by COLLAGEN MATRIX, INC.
- SYMBIOS 32310006 by COLLAGEN MATRIX, INC.
- GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O by Geistlich Pharma AG
- InterOss Collagen by Sigmagraft, Inc.
- BOSS by Medpark Co., Ltd.
- Equimatrix by LUITPOLD PHARMACEUTICALS, INC.
- Wishbone HA by Wishbone SA
- Graft Bone Substitute by PURGO BIOLOGICS Inc.