FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
K Number: K103474
·
Decision Feb 7, 2011
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
6
Review Days
73
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Basic Information
- Device Name
- ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
- K Number
- K103474
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micerium S.P.A.
- Date Received
- November 26, 2010
- Decision Date
- February 7, 2011
- 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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|---|---|---|---|
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| K063170 | TENDER FIBER | Jan 12, 2007 | Substantially Equivalent |
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| K062367 | MINISCREWS ANCHORING SYSTEM, M.A.S. | Dec 8, 2006 | Substantially Equivalent |
| K062906 | ENA HFO COMPOSITE SYSTEM | Nov 17, 2006 | Substantially Equivalent |