FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPI VARIOMULTI ANGLED ABUTMENT
K Number: K101798
·
Decision Aug 19, 2010
Classifications
1
FEI Numbers
390
Registration Numbers
390
Same Product Code
672
Applicant Total
23
Review Days
52
Basic Information
- Device Name
- SPI VARIOMULTI ANGLED ABUTMENT
- K Number
- K101798
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- THOMMEN MEDICAL, AG
- Date Received
- June 28, 2010
- Decision Date
- August 19, 2010
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.
Sherlock
FDA 510(k)
FDA Class 2
·Dental
MIST IC
FDA 510(k)
FDA Class 2
·Dental
Geo Abutment
FDA 510(k)
FDA Class 2
·Dental
Dynamic TiBase
FDA 510(k)
FDA Class 2
·Dental
Neodent Implant System - Custom Abutments
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by THOMMEN MEDICAL, AG
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |
| K072856 | SPI VARIOMULTI ABUTMENT | Feb 15, 2008 | Substantially Equivalent |
| K072649 | SPI SYSTEM DENTAL IMPLANTS | Dec 6, 2007 | Substantially Equivalent |
| K073141 | SPI ART ABUTMENT | Dec 5, 2007 | Substantially Equivalent |