510(k) · Cleared
ClearedUltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Product, Inc. · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Aug 18, 2023 as substantially equivalent to K993846 (Ultradent Products, Inc., 2000) and 1 other predicate after a 1-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Aug 18, 2023
- Review
- 1 day
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993846 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993846 | Ultraseal XT Plus | Ultradent Products, Inc. | 2000 | 1 |
| −1 | K112517 | Ultraseal XT Hydro | Ultradent Products, Inc. | 2011 | — |
| 0 (this device) | K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection… | Ultradent Product, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBC device
- #1 K243254 Parkell Pit and Fissure Sealantscore 12.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993846 | Ultraseal XT PlusSummary page 6…f the bioprotection by Nobio reduces demineralization, which is part of the caries formation process. V. Predicate Device Predicate Identified: UltraSeal XT plus K993846 UltraSeal XT hydro K112517 Infinix Universal Composite, Infinix Flowable Co… | 2000 |
| * | K112517 | Ultraseal XT HydroSummary page 6…which is part of the caries formation process. V. Predicate Device Predicate Identified: UltraSeal XT plus K993846 UltraSeal XT hydro K112517 Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill… | 2011 |
| † | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K993846.
How does its category compare?
All EBC devicesEBC Sealant, Pit And Fissure, And Conditioner: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBC
80in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBC
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBC
6in 2025
MAUDE reports naming product code EBC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 5 | 115 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 5 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 11 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 1 | — | 2 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232498: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232498
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026