FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
SFI-ANCHOR
K Number: K130618
·
Decision Mar 3, 2014
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
6
Review Days
361
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Basic Information
- Device Name
- SFI-ANCHOR
- K Number
- K130618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cendres & Metaux SA
- Date Received
- March 7, 2013
- Decision Date
- March 3, 2014
- 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 Cendres & Metaux SA
| K Number | Device Name | ||
|---|---|---|---|
| K131526 | SFI-BAR | Sep 23, 2013 | Substantially Equivalent |
| K123638 | PEKKTON IVORY | Feb 21, 2013 | Substantially Equivalent |
| K111390 | SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. | Sep 12, 2011 | Substantially Equivalent |
| K102382 | SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT | Dec 3, 2010 | Substantially Equivalent |
| K083876 | SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT | Feb 26, 2010 | Substantially Equivalent |