# K993846: Ultraseal XT Plus

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Feb 16, 2000 after 96 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- 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.
3 later devices descend from it; 3 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112517: Ultraseal XT Hydro (2011), 1 descendant of its own
- K232498: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio (2023), 0 descendants of its own
- K101245: Ultraseal ID (2010), 0 descendants of its own

## Recalls of this device
- Nov 17, 2016 · Class II · Z-0704-2017: There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products we

## Indications for use
Use UltraSeal XT plus for prophylactic sealing of pits and fissures. It may also be used for microrestorative or “initial layer” of composite restorations.

Source page: https://510kreport.com/device/K993846
Methodology: https://510kreport.com/methodology