# K112517: Ultraseal XT Hydro

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Sep 23, 2011 after 23 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- 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 K993846 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993846: Ultraseal XT Plus, Ultradent Products, Inc. (2000) Summary page 1.
- K052281: Embrace Wetbond Clear Sealant, Pulpdent Corporation (2006) Summary page 1.

## Most influential descendants
- K232498: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio (2023), 0 descendants of its own

## Indications for use
Use UltraSeal XT® hydro™ for prophylactic sealing of pits and fissures.

Source page: https://510kreport.com/device/K112517
Methodology: https://510kreport.com/methodology