# K211905: UltraCal XS

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Oct 13, 2021 after 114 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: 9 generations back to K990131 (1999). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210333: DiaPaste, DiaDent Group International (2021) Summary page 5.
- K201799: CleaniCal, Maruchi (2021) Summary page 5.
- K180344: TheraCal DC, Bisco, Inc. (2018) Summary page 5.
- K200174: Dia-Root Bio Mta, DiaDent Group International (2020) Summary page 5.

## Indications for use
UltraCal XS calcium hydroxide paste is indicated to be used for: • temporary dressing for root canals • apexification and/or perforation • vital pulpotomy • direct pulp capping • indirect pulp capping • root resorption • root canal filling for primary teeth

Source page: https://510kreport.com/device/K211905
Methodology: https://510kreport.com/methodology