FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
ELECTROmatic
K Number: K163317
·
Decision Feb 21, 2017
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
1
Review Days
90
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Basic Information
- Device Name
- ELECTROmatic
- K Number
- K163317
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kaltenbach & Voigt Gmgh
- Date Received
- November 23, 2016
- Decision Date
- February 21, 2017
- Product Code
- EBW
- 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 |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | FDA class 1 | Dental |
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