FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
TENDER ORTHO BOND-ENA BOND-ENA ETCH
K Number: K072978
·
Decision Jan 17, 2008
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
6
Review Days
87
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Basic Information
- Device Name
- TENDER ORTHO BOND-ENA BOND-ENA ETCH
- K Number
- K072978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micerium S.P.A.
- Date Received
- October 22, 2007
- Decision Date
- January 17, 2008
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
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Other Clearances by Micerium S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) | Feb 7, 2011 | Substantially Equivalent |
| K063170 | TENDER FIBER | Jan 12, 2007 | Substantially Equivalent |
| K062355 | ENA CEM | Dec 27, 2006 | Substantially Equivalent |
| K062367 | MINISCREWS ANCHORING SYSTEM, M.A.S. | Dec 8, 2006 | Substantially Equivalent |
| K062906 | ENA HFO COMPOSITE SYSTEM | Nov 17, 2006 | Substantially Equivalent |