Navina Smart System, Navina Classic System
FDA 510(k) clearance K190977 · decided 2019-11-22
Clearance details
- K-number
- K190977
- Device name
- Navina Smart System, Navina Classic System
- Applicant
- Dentsply Sirona
- Decision
- Substantially Equivalent
- Date received
- 2019-04-15
- Decision date
- 2019-11-22
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.