FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPI CONTACT PLATFORM O 4.0 MM
K Number: K072933
·
Decision Nov 15, 2007
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
26
Review Days
30
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Basic Information
- Device Name
- SPI CONTACT PLATFORM O 4.0 MM
- K Number
- K072933
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thommen Medical AG
- Date Received
- October 16, 2007
- Decision Date
- November 15, 2007
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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| 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 |