510(k) K131907
K131907 is an FDA 510(k) premarket notification submitted by Dentsply International, Inc. for the device "RAYPEX 6". The FDA issued a decision of Substantially Equivalent on January 31, 2014. The device falls under product code LQY (Locator, Root Apex), a Class U device. Dentsply International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2014
- Date Received
- June 26, 2013
- 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