FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
BlueCheck Caries Detection & Monitoring
K Number: K222560
·
Decision May 16, 2023
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
1
Review Days
265
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Basic Information
- Device Name
- BlueCheck Caries Detection & Monitoring
- K Number
- K222560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Incisive Technologies Pty, Ltd.
- Date Received
- August 24, 2022
- Decision Date
- May 16, 2023
- Product Code
- LFC
- 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 |
|---|---|---|---|
| LFC | Device, Caries Detection | FDA class 2 | Dental |
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