510(k) K190977
K190977 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Navina Smart System, Navina Classic System". The FDA issued a decision of Substantially Equivalent on Nov 22, 2019. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Dentsply Sirona has 87 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 22, 2019
- Date Received
- Apr 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)