510(k) K150222
K150222 is an FDA 510(k) premarket notification submitted by X-Nav Technologies, LLC for the device "X-Guide Surgical Navigation System". The FDA issued a decision of Substantially Equivalent on October 8, 2015. The device falls under product code PLV (Dental Stereotaxic Instrument), a Class II device regulated under 21 CFR 872.4120. X-Nav Technologies, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2015
- Date Received
- January 30, 2015
- 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
To facilitate dental implant placement in patients that are partially endentulous or edentulous.