FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ADHESIVE EXL-759
K Number: K110302
·
Decision May 19, 2011
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
6
Review Days
106
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Basic Information
- Device Name
- ADHESIVE EXL-759
- K Number
- K110302
- 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
- Date Received
- February 2, 2011
- Decision Date
- May 19, 2011
- 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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| K120011 | HEISENBERG EFFECT SHADES | Jan 13, 2012 | Substantially Equivalent |
| K110508 | SUGLUE-10 | Jun 3, 2011 | Substantially Equivalent |
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