510(k) K113246
K113246 is an FDA 510(k) premarket notification submitted by Nibec Company, Limited for the device "OCS-B". The FDA issued a decision of Substantially Equivalent on Jan 16, 2013. The device falls under product code NPM (Bone Grafting Material, Animal Source), a Class II device regulated under 21 CFR 872.3930.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 16, 2013
- Date Received
- Nov 2, 2011
- 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
- 510(k)
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.