FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Franz Zirconia Dental Crown
K Number: K203072
·
Decision Jan 19, 2022
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
38
Applicant Total
1
Review Days
467
Basic Information
- Device Name
- Franz Zirconia Dental Crown
- K Number
- K203072
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Franz Biotech Inc.
- Date Received
- October 9, 2020
- Decision Date
- January 19, 2022
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
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