FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cleo
K Number: K232011
·
Decision Jul 7, 2023
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
45
Review Days
1
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Basic Information
- Device Name
- Cleo
- K Number
- K232011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Orthodontics
- Date Received
- July 6, 2023
- Decision Date
- July 7, 2023
- Product Code
- NJM
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | FDA class 2 | Dental |
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