FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
VARIOunite
K Number: K160244
·
Decision Jun 2, 2016
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
26
Review Days
122
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Basic Information
- Device Name
- VARIOunite
- K Number
- K160244
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thommen Medical AG
- Date Received
- February 1, 2016
- Decision Date
- June 2, 2016
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Thommen Medical AG
| K Number | Device Name | ||
|---|---|---|---|
| K171795 | Thommen Implant System | Sep 29, 2017 | 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 |
| K090153 | SPI VARIOMULTI ANGLED ABUTMENT | Mar 27, 2009 | Substantially Equivalent |