510(k) K151274
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2016
- Date Received
- May 13, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type