SPI VECTODRILL CERAMIC DRILLS
FDA 510(k) clearance K070290 · decided 2007-04-17
Clearance details
- K-number
- K070290
- Device name
- SPI VECTODRILL CERAMIC DRILLS
- Applicant
- Thommen Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2007-01-30
- Decision date
- 2007-04-17
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- NDP
- Device class
- 1
- Regulation number
- 872.3980
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.