FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VITA ENAMIC Implant Solutions (IS)
K Number: K153645
·
Decision Jun 30, 2016
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
2
Review Days
192
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Basic Information
- Device Name
- VITA ENAMIC Implant Solutions (IS)
- K Number
- K153645
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vita Zahnfabrik H.Rauter GmbH Co.
- Date Received
- December 21, 2015
- Decision Date
- June 30, 2016
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Vita Zahnfabrik H.Rauter GmbH Co.
| K Number | Device Name | ||
|---|---|---|---|
| K180703 | VITA YZ ST and VITA YZ XT | Aug 1, 2018 | Substantially Equivalent |