510(k) K130949
K130949 is an FDA 510(k) premarket notification submitted by Biomet 3i for the device "CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on July 30, 2013. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Biomet 3i has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2013
- Date Received
- April 5, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type