Ossix Plus
510(k) K160281
Ossix Plus is a Class II device made by Datum Dental Ltd, cleared under FDA 510(k) K160281 on 4 Aug 2016, 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 | NumberK160281 | Date4 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K160281
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NPL
- 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 K160281
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® PLUS OXP1525 | OXP1525 | 07290015477765 | Length 25 mm; Width 15 mm | On the market |
| OSSIX® PLUS OXP2530 | OXP2530 | 07290015477727 | Length 30 mm; Width 25 mm | On the market |
| OSSIX® PLUS OXP3040 | OXP3040 | 07290015477710 | Length 40 mm; Width 30 mm | On the market |
Similar devices
Other devices filed under FDA product code NPL (Barrier, Animal Source, Intraoral).
- Kontour™ Adapt KRMA1520 by IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Neomem FlexPlus NF3040 by COLLAGEN MATRIX, INC.
- OSSIX -PLUS by Colbar Lifescience, Ltd.
- KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE by Kensey Nash Corp.
- Kontour™ Adapt KRMA3040 by IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Mem-Lok RCM-ML3040 by COLLAGEN MATRIX, INC.
- COVAMAX RESORBABLE COLLAGEN MEMBRANE by Biom'Up Sas
- MATRICEL DENTAL BARRIER MEMBRANE by Matricel GmbH
- MESOTHELIUM DENTAL MEMBRANE by Kensey Nash Corp.
- VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE by Obi Biologics, Inc.