FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
UNO
K Number: K071131
·
Decision Jul 25, 2007
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
24
Review Days
93
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Basic Information
- Device Name
- UNO
- K Number
- K071131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Espe AG Dental Products
- Date Received
- April 23, 2007
- Decision Date
- July 25, 2007
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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|---|---|---|---|
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| K093721 | COSP2 | Feb 19, 2010 | Substantially Equivalent |
| K091826 | ELEGANT | Sep 25, 2009 | Substantially Equivalent |
| K090718 | BELLUS SHADING KIT | Sep 21, 2009 | Substantially Equivalent |
| K080514 | PECD-01 AND PECD QUICK-01 | Mar 26, 2008 | Substantially Equivalent |
| K072055 | LAVA FRAME, LAVA FRAME SHADE | Feb 26, 2008 | Substantially Equivalent |
| K073296 | TEMPXN28 | Jan 9, 2008 | Substantially Equivalent |
| K071260 | HERMES BOND 3 | Jul 17, 2007 | Substantially Equivalent |