The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Propex Iq Apex Locator.
| Device ID | K191806 |
| 510k Number | K191806 |
| Device Name: | Propex IQ Apex Locator |
| Classification | Locator, Root Apex |
| Applicant | Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 |
| Contact | Karl Nittinger |
| Correspondent | Karl Nittinger Dentsply Sirona 221 West Philadelphia Street Suite 60W 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 | 2019-07-05 |
| Decision Date | 2019-10-03 |