FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENAMIC
K Number: K122269
·
Decision Dec 13, 2012
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
6
Review Days
136
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Basic Information
- Device Name
- ENAMIC
- K Number
- K122269
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vita Zahnfabrik H.Rauter GmbH & Co.
- Date Received
- July 30, 2012
- Decision Date
- December 13, 2012
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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