FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MALTA
K Number: K100756
·
Decision Jun 2, 2010
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
24
Review Days
77
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Basic Information
- Device Name
- MALTA
- K Number
- K100756
- 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 Dental Products
- Date Received
- March 17, 2010
- Decision Date
- June 2, 2010
- 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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| K073296 | TEMPXN28 | Jan 9, 2008 | Substantially Equivalent |
| K071131 | UNO | Jul 25, 2007 | Substantially Equivalent |
| K071260 | HERMES BOND 3 | Jul 17, 2007 | Substantially Equivalent |