FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Eagle S/Saevo Slim/D700 Slim
K Number: K230732
·
Decision Apr 11, 2023
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
1
Review Days
26
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Basic Information
- Device Name
- Eagle S/Saevo Slim/D700 Slim
- K Number
- K230732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alliage S/A Industrias Medica Odontológico.
- Date Received
- March 16, 2023
- Decision Date
- April 11, 2023
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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