# K232498: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Product, Inc.
- Decided: Aug 18, 2023 after 1 day
- 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: 2 generations back to K993846 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
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 6.
- K112517: Ultraseal XT Hydro, Ultradent Products, Inc. (2011) Summary page 6.

## Indications for use
UltraSeal XT plus bioprotection by Nobio sealant - UltraSeal XT plus sealant for prophylactic sealing of pits and fissures and can be used where the use of a flowable composite is indicated. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process. UltraSeal XT hydro bioprotection by Nobio sealant - Use UltraSeal XT hydro sealant for prophylactic sealing of pits and fissures. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

Source page: https://510kreport.com/device/K232498
Methodology: https://510kreport.com/methodology