510(k) K091387
K091387 is an FDA 510(k) premarket notification submitted by B.T.I. Biotechnology Institute, Sl. for the device "BTI DENTAL IMPLANT 5.5-6.5". The FDA issued a decision of Substantially Equivalent on January 22, 2010. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. B.T.I. Biotechnology Institute, Sl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2010
- Date Received
- May 11, 2009
- 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