FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
C50
K Number: K223470
·
Decision Dec 14, 2023
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
23
Applicant Total
25
Review Days
392
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Basic Information
- Device Name
- C50
- K Number
- K223470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1745
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sopro
- Date Received
- November 17, 2022
- Decision Date
- December 14, 2023
- Product Code
- NBL
- 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 |
|---|---|---|---|
| NBL | Laser, Fluorescence Caries Detection | FDA class 2 | Dental |
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Other Clearances by Sopro
| K Number | Device Name | ||
|---|---|---|---|
| K121685 | SOPROCARE | Mar 12, 2013 | Substantially Equivalent |
| K103813 | SOPRO 281 | Mar 22, 2011 | Substantially Equivalent |
| K092329 | SOPIX 2 | Jul 20, 2010 | Substantially Equivalent |
| K092583 | SOPROLIFE | Jan 13, 2010 | Substantially Equivalent |
| K082796 | SOPRO 184 CAMERA | Apr 1, 2009 | Substantially Equivalent |
| K080122 | SOPRO 670 ARTHROSCOPIC PUMP | Jul 11, 2008 | Substantially Equivalent |
| K070783 | SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR | Dec 13, 2007 | Substantially Equivalent |
| K072912 | SOPRO 225 DUAL HALOGEN LIGHT SOURCE | Nov 16, 2007 | Substantially Equivalent |
| K070102 | SOPRO 162 CAMERA | Feb 20, 2007 | Substantially Equivalent |
| K031593 | SOPRO 61D | Sep 16, 2003 | Substantially Equivalent |