# K152956: Pulp Canal Sealer, Pulp Canal Sealer EWT

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties
- Decided: May 6, 2016 after 212 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 K945244 (1994). 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)
- K945244: Pulp Canal Sealer Ewt, Sybron Dental Specialties, Inc. (1994) 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
Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.

Source page: https://510kreport.com/device/K152956
Methodology: https://510kreport.com/methodology