# K010940: Sealapex 4

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Jun 20, 2001 after 83 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113568: Mta-Fillapex (2012), 12 descendants of its own
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K201799: CleaniCal (2021), 2 descendants of its own
- K140247: Mta Fillapex (2014), 2 descendants of its own
- K202015: White ENDOSEAL MTA (2021), 1 descendant of its own

## Recalls of this device
- Aug 31, 2016 · Class II · Z-2836-2016: SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.

Source page: https://510kreport.com/device/K010940
Methodology: https://510kreport.com/methodology