# K053167: Biopure Mtad Root Canal Cleanser

- Pathway: 510(k) (Special)
- Applicant: Dentsply Intl., Inc.
- Decided: Dec 8, 2005 after 24 days
- Product code: KJJ (Cleanser, Root Canal)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003422 (2001). 2 ancestors in all.
63 later devices descend from it; 9 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032361: Endopure Root Canal Cleanser, Dentsply Intl. (2004) Summary page 1.

## Most influential descendants
- K071363: Waterlase and Waterlase MD (2008), 28 descendants of its own
- K090181: Waterlase MD (2009), 26 descendants of its own
- K101658: Waterlase MD Turbo Plus Model 7200XXX (2010), 25 descendants of its own
- K161669: Waterlase Express (2016), 21 descendants of its own
- K190319: Waterlase Laser System Family (2019), 19 descendants of its own

## Indications for use
BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.

Source page: https://510kreport.com/device/K053167
Methodology: https://510kreport.com/methodology