# K152959: Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

- Pathway: 510(k) (Special)
- Applicant: Sybron Dental Specialties
- Decided: Apr 14, 2016 after 190 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: 1 generation back to K010940 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010940: Sealapex 4, Sybron Dental Specialties, Inc. (2001) Summary page 4.

## Most influential descendants
- K212563: CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid (2022), 0 descendants of its own

## Indications for use
Sealapex/ Sealapex Xpress is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

Source page: https://510kreport.com/device/K152959
Methodology: https://510kreport.com/methodology