FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
Provicol QM Plus
K Number: K161630
·
Decision Sep 15, 2016
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
10
Applicant Total
119
Review Days
94
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Basic Information
- Device Name
- Provicol QM Plus
- K Number
- K161630
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Voco GmbH
- Date Received
- June 13, 2016
- Decision Date
- September 15, 2016
- Product Code
- EMB
- 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 |
|---|---|---|---|
| EMB | Zinc Oxide Eugenol | FDA class 1 | Dental |
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