# K142178: Proroot Mta White, Proroot Mta Gray

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Feb 26, 2015 after 202 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964174 (1997). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011009: White Mta Material, Dentsply International (2001) Summary page 4.
- K981620: Mta Material II, Dentsply Intl. (1998). Our OCR of the scanned summary read K981260, FDA’s number for Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi… (Clinical Innovations, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “MTA Material II”. Summary page 4.

## Most influential descendants
- K252285: Well-Root PT (2025), 0 descendants of its own
- K222992: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material (2022), 0 descendants of its own
- K162661: SavDenTM MTA Root Canal Filling Materials (2017), 0 descendants of its own

## Indications for use
A root end filling material For the repair of repair of root canals as an apical plug during apexification For repair of root perforations during root canal therapy or as a consequence of internal resorption As a pulp capping material Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations

Source page: https://510kreport.com/device/K142178
Methodology: https://510kreport.com/methodology