FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SUGLUE-10
K Number: K110508
·
Decision Jun 3, 2011
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
6
Review Days
101
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Basic Information
- Device Name
- SUGLUE-10
- K Number
- K110508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Espe AG
- Date Received
- February 22, 2011
- Decision Date
- June 3, 2011
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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| K Number | Device Name | ||
|---|---|---|---|
| K140602 | FLASH PENTA MB QUICK, FLASH MB QUICK | Jun 5, 2014 | Substantially Equivalent |
| K133400 | FLASH BITE | Mar 6, 2014 | Substantially Equivalent |
| K120011 | HEISENBERG EFFECT SHADES | Jan 13, 2012 | Substantially Equivalent |
| K110302 | ADHESIVE EXL-759 | May 19, 2011 | Substantially Equivalent |
| K111257 | HEISENBERG DYEING LIQUIDS | May 13, 2011 | Substantially Equivalent |