510(k) K153230
K153230 is an FDA 510(k) premarket notification submitted by The Implantech Inc./Shefabone for the device "ShefaBone SCPC Resorbable Bone Graft". The FDA issued a decision of Substantially Equivalent on Jul 14, 2016. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 14, 2016
- Date Received
- Nov 6, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Bone Grafting Material, Synthetic
- Device Class
- Class II
- Regulation Number
- 872.3930
- Review Panel
- DE
- Submission Type
- 510(k)
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.