FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
PEKKTON IVORY
K Number: K123638
·
Decision Feb 21, 2013
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
6
Review Days
87
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Basic Information
- Device Name
- PEKKTON IVORY
- K Number
- K123638
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cendres & Metaux SA
- Date Received
- November 26, 2012
- Decision Date
- February 21, 2013
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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Other Clearances by Cendres & Metaux SA
| K Number | Device Name | ||
|---|---|---|---|
| K130618 | SFI-ANCHOR | Mar 3, 2014 | Substantially Equivalent |
| K131526 | SFI-BAR | Sep 23, 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 |