510(k) K153549
K153549 is an FDA 510(k) premarket notification submitted by Datum Dental, Ltd. for the device "OSSIX VOLUMAX". The FDA issued a decision of Substantially Equivalent on August 4, 2016. The device falls under product code NPL (Barrier, Animal Source, Intraoral), a Class II device regulated under 21 CFR 872.3930. Datum Dental, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2016
- Date Received
- December 11, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barrier, Animal Source, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.3930
- Review Panel
- DE
- Submission Type
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.