# K200174: Dia-Root Bio Mta

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Sep 18, 2020 after 239 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: 4 generations back to K011009 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112046: Mta Angelus, Angelus Industria DE Productos Odontologicos (2012) Summary page 4.

## Most influential descendants
- K211905: UltraCal XS (2021), 0 descendants of its own

## Indications for use
DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.

Source page: https://510kreport.com/device/K200174
Methodology: https://510kreport.com/methodology