510(k) K103709
K103709 is an FDA 510(k) premarket notification submitted by Curasan AG for the device "CERACELL DENTAL". The FDA issued a decision of Substantially Equivalent on March 10, 2011. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Curasan AG has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2011
- Date Received
- December 20, 2010
- Clearance Type
- Abbreviated
- 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
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.