# K253909: NeoPEX™ Pre-Mixed Obturation Paste

- Pathway: 510(k) (Traditional)
- Applicant: NuSmile, Ltd.
- Decided: Sep 4, 2026 after 270 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: 10 generations back to K990131 (1999). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250710: Injectable Root Canal Bioceramic Sealer (nRoot SP), Enpuno Co., Ltd. (2025) Summary page 5.

## Indications for use
Obturation and sealing of root canals following extirpation and pulpectomy Vital Pulpotomy Pulp capping Repair of Root Resorption Apexification and/or Perforations Root canal filling for primary teeth

Source page: https://510kreport.com/device/K253909
Methodology: https://510kreport.com/methodology