510(k) K151391
K151391 is an FDA 510(k) premarket notification submitted by B.T.I. Biotechnology Institute, Sl. for the device "BTI Dental Implant System UnicCa". The FDA issued a decision of Substantially Equivalent on May 2, 2016. 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
- May 2, 2016
- Date Received
- May 26, 2015
- 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