510(k) K070290
K070290 is an FDA 510(k) premarket notification submitted by Thommen Medical AG for the device "SPI VECTODRILL CERAMIC DRILLS". The FDA issued a decision of Substantially Equivalent on April 17, 2007. The device falls under product code NDP (Accessories, Implant, Dental, Endosseous), a Class I device regulated under 21 CFR 872.3980. Thommen Medical AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2007
- Date Received
- January 30, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Implant, Dental, Endosseous
- Device Class
- Class I
- Regulation Number
- 872.3980
- Review Panel
- DE
- Submission Type