FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
FONA XDC
K Number: K222274
·
Decision Aug 23, 2022
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
4
Review Days
25
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Basic Information
- Device Name
- FONA XDC
- K Number
- K222274
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fona S.R.L
- Date Received
- July 29, 2022
- Decision Date
- August 23, 2022
- Product Code
- EHD
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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