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 |