# K261514: Calcium Hydroxide Temporary Filling Material (KP-Cal)

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Kevin Peter Technology Co., Ltd.
- Decided: Aug 25, 2026 after 110 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 K944945 (1994). 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)
- K210904: Metapaste Plus, Meta Biomed Co., Ltd. (2021) Summary page 5.
- K060365: Apexcal, Ivoclar Vivadent, Inc. (2006) Summary page 6.

## Indications for use
Calcium Hydroxide Temporary Filling Material is suitable for several indications including： -Temporary root canal filling; -Vital pulpotomy -Temporary pulp capping.

Source page: https://510kreport.com/device/K261514
Methodology: https://510kreport.com/methodology