510(k) K163714
K163714 is an FDA 510(k) premarket notification submitted by Datum Dental, Ltd. for the device "OSSIX BONE". The FDA issued a decision of Substantially Equivalent on July 18, 2017. The device falls under product code NPM (Bone Grafting Material, Animal Source), 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
- July 18, 2017
- Date Received
- December 30, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Grafting Material, Animal Source
- Device Class
- Class II
- Regulation Number
- 872.3930
- Review Panel
- DE
- Submission Type
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.