FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPI VECTODRILL CERAMIC DRILLS
K Number: K070290
·
Decision Apr 17, 2007
Classifications
1
FEI Numbers
523
Registration Numbers
523
Same Product Code
3
Applicant Total
26
Review Days
77
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPI VECTODRILL CERAMIC DRILLS
- K Number
- K070290
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3980
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thommen Medical AG
- Date Received
- January 30, 2007
- Decision Date
- April 17, 2007
- Product Code
- NDP
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NDP), ordered by most recent decision date.
Simplant Digital Guide
FDA 510(k)
FDA Class 1
·Dental
CEREC Guides
FDA 510(k)
FDA Class 1
·Dental
SIMPLANT Guide
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Thommen Medical AG
| K Number | Device Name | ||
|---|---|---|---|
| K171795 | Thommen Implant System | Sep 29, 2017 | Substantially Equivalent |
| K160244 | VARIOunite | Jun 2, 2016 | Substantially Equivalent |
| K151984 | Thommen Milling Abutment for CAD/CAM | Mar 10, 2016 | Substantially Equivalent |
| K121334 | VARIOECO | Aug 14, 2012 | Substantially Equivalent |
| K111984 | SPI VARIO ANGLED ABUTMENT | Nov 10, 2011 | Substantially Equivalent |
| K102804 | SPI TITANIUM BASE FOR CAD/CAM | Apr 20, 2011 | Substantially Equivalent |
| K101798 | SPI VARIOMULTI ANGLED ABUTMENT | Aug 19, 2010 | Substantially Equivalent |
| K093615 | SPI DENTAL IMPLANT, ELEMENT | Mar 4, 2010 | Substantially Equivalent |
| K092248 | SPI CUSTOMIZABLE GINGIVA FORMER | Sep 25, 2009 | Substantially Equivalent |
| K090154 | SPI DENTAL IMPLANT INICELL | Jul 27, 2009 | Substantially Equivalent |