# K153067: Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties
- Decided: Jul 27, 2016 after 279 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 K942393 (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)
- K942393: Tubli-Seal 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
The Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.

Source page: https://510kreport.com/device/K153067
Methodology: https://510kreport.com/methodology