The following data is part of a premarket notification filed by Dentsply International Inc. with the FDA for Raypex 6.
| Device ID | K131907 |
| 510k Number | K131907 |
| Device Name: | RAYPEX 6 |
| Classification | Locator, Root Apex |
| Applicant | DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-26 |
| Decision Date | 2014-01-31 |
| Summary: | summary |