FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
DuoCem
K Number: K160800
·
Decision Nov 16, 2016
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
16
Review Days
238
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Basic Information
- Device Name
- DuoCem
- K Number
- K160800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coltene/Whaledent AG
- Date Received
- March 23, 2016
- Decision Date
- November 16, 2016
- 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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