The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Endopure Root Canal Cleanser.
| Device ID | K032361 |
| 510k Number | K032361 |
| Device Name: | ENDOPURE ROOT CANAL CLEANSER |
| Classification | Cleanser, Root Canal |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVENUE P.O. BOX 872 York, PA 17405 -0872 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVENUE P.O. BOX 872 York, PA 17405 -0872 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-07-31 |
| Decision Date | 2004-01-12 |
| Summary: | summary |