510(k) K213392
K213392 is an FDA 510(k) premarket notification submitted by Navigate Surgical Technologies, Inc. for the device "INLIANT Surgical Navigation System". The FDA issued a decision of Substantially Equivalent on Feb 22, 2022. The device falls under product code PLV (Dental Stereotaxic Instrument), a Class II device regulated under 21 CFR 872.4120.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 2022
- Date Received
- Oct 15, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type
- 510(k)
To facilitate dental implant placement in patients that are partially endentulous or edentulous.