510(k) · Cleared
ClearedUltraseal ID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Sep 17, 2010 as substantially equivalent to K993846 (Ultradent Products, Inc., 2000) and 1 other predicate after a 136-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 17, 2010
- Review
- 136 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951296 (1995). 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 | K951296 | Delton F Pit & Fissure Sealant | Dentsply Intl. | 1995 | — |
| −1 | K050959 | Delton Illuminating Pit and Fissure Sealing | Dentsply International | 2005 | — |
| 0 (this device) | K101245 | Ultraseal ID | Ultradent Products, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 2…ork, PA 17405'0872 Brief Description of testing performed The following tests were conducted during the R& D phase on UltraSeal ID and compared to UltraSeal XT plus (K(993846) and Delton® Illuminating Pit and Fissure Sealant Seal-n-Glo (K(050959). Test results are included in this 510(k). a. Hardne… | 2000 |
| * | K050959 | Delton Illuminating Pit and Fissure SealingSummary page 1…assification Product Code: EBC Legally Marketed Predicate Device to Which Equivalence is Claimed Ultradent's Ultra~eal XT plus (1(050959) and Seal-n -Glo (K(050959) are similar in that they all are Pit and Fissure Sealants. Seal-n-Glo and UltraSeal ID cont… | 2005 |
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 15 years and passes through 3 companies; a new generation was cleared every 10.0 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. 2010, 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?
Use UltraSeal ID for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101245: Ultraseal ID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101245
Report an extraction error
Are you the manufacturer?
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