FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
MINISCREWS ANCHORING SYSTEM, M.A.S.
K Number: K062367
·
Decision Dec 8, 2006
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
6
Review Days
116
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Basic Information
- Device Name
- MINISCREWS ANCHORING SYSTEM, M.A.S.
- K Number
- K062367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micerium S.P.A.
- Date Received
- August 14, 2006
- Decision Date
- December 8, 2006
- 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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|---|---|---|---|
| K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) | Feb 7, 2011 | Substantially Equivalent |
| K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | Jan 17, 2008 | Substantially Equivalent |
| K063170 | TENDER FIBER | Jan 12, 2007 | Substantially Equivalent |
| K062355 | ENA CEM | Dec 27, 2006 | Substantially Equivalent |
| K062906 | ENA HFO COMPOSITE SYSTEM | Nov 17, 2006 | Substantially Equivalent |