# K190091: Diapaste

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Mar 27, 2020 after 434 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: 2 generations back to K944945 (1994). 3 ancestors in all.
2 later devices descend 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)
- K032605: Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling, Meta Biomed Co., Ltd. (2003) Summary page 4.

## Most influential descendants
- K210333: DiaPaste (2021), 1 descendant of its own
- K211905: UltraCal XS (2021), 0 descendants of its own

## Indications for use
Aqueous ointment material that temporarily fills the root canal for the following indications: - Apexification - Temporary root filling - Root canal filling for primary teeth - Vital pulpotomy - Temporary pulp capping

Source page: https://510kreport.com/device/K190091
Methodology: https://510kreport.com/methodology