FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
DEXIS CariVu 3-in-1 by KaVo
K Number: K182712
·
Decision Nov 23, 2019
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
10
Applicant Total
9
Review Days
422
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Basic Information
- Device Name
- DEXIS CariVu 3-in-1 by KaVo
- K Number
- K182712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1745
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kaltenbach & Voigt GmbH
- Date Received
- September 27, 2018
- Decision Date
- November 23, 2019
- Product Code
- NTK
- 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 |
|---|---|---|---|
| NTK | Caries Detector, Laser Light, Transmission | FDA class 2 | Dental |
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| K140308 | MASTERSURG / EXPERTSURG | Aug 15, 2014 | Substantially Equivalent |
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