FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Navident
K Number: K210947
·
Decision Jun 27, 2022
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
22
Applicant Total
4
Review Days
454
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Basic Information
- Device Name
- Navident
- K Number
- K210947
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Claronav, Inc.
- Date Received
- March 30, 2021
- Decision Date
- June 27, 2022
- Product Code
- PLV
- 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 |
|---|---|---|---|
| PLV | Dental Stereotaxic Instrument | FDA class 2 | Dental |
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