FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nexus Universal Self-Cure
K Number: K191548
·
Decision Oct 11, 2019
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
32
Review Days
121
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Basic Information
- Device Name
- Nexus Universal Self-Cure
- K Number
- K191548
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kerr Corporation
- Date Received
- June 12, 2019
- Decision Date
- October 11, 2019
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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