510(k) K170541
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2017
- Date Received
- February 23, 2017
- 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.