# K162661: SavDenTM MTA Root Canal Filling Materials

- Pathway: 510(k) (Traditional)
- Applicant: Tyds Biotech Incorporation
- Decided: Apr 25, 2017 after 211 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 K964174 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142178: Proroot Mta White, Proroot Mta Gray, Dentsply International, Inc. (2015) Summary page 6.

## Indications for use
- A root end filling material. - For the 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/K162661
Methodology: https://510kreport.com/methodology