510(k) · Cleared
ClearedFiteBac CC OrthoSeal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Largent Health, LLC · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Jul 29, 2021 as substantially equivalent to K090355 (Ultradent Products, Inc., 2009) and 1 other predicate after a 191-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Jul 29, 2021
- Review
- 191 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K023042 (2002). 3 ancestors in all, the oldest K880393 (1988). 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 | K023042 | PQ1 | Ultradent Products, Inc. | 2002 | — |
| −1 | K090355 | Opal Seal | Ultradent Products, Inc. | 2009 | — |
| 0 (this device) | K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 DYH? 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 DYH device
- #1 K261840 BracePaste Prime Plusscore 13.8 · 9 generations · 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 |
|---|---|---|---|
| * | K090355 | Opal SealSummary page 5…Marietta, GA 30064 4. Primary Predicate Device: Trade Name: Ultradent Opal® Seal™ 510(k) Clearance: K090355 Clearance Date: April 29, 2009 Classification Name: Bracket adhesive resin and… | 2009 |
| * | K880393 | Transbond Light Cured Orthodontic AdhesiveSummary page 5…Transbond Light Cured Orthodontic Adhesive (Transbond XT Primer) 510(k) Clearance: K880393 Clearance Date: March 31, 1988 Classification Name: Bracket adhesive resin and… | 1988 |
| † | K163482 | Orthodontic Acrylic 2 | 2017 |
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 19 years and passes through 2 companies; a new generation was cleared every 12.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K090355.
How does its category compare?
All DYH devicesDYH Adhesive, Bracket And Tooth Conditioner, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DYH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYH
143in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYH
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYH
1in 2025
MAUDE reports naming product code DYH, 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 | 3 | 62 | 1 | 2 |
| 2008 | 6 | 72 | 0 | 1 |
| 2009 | 3 | 77 | 0 | 1 |
| 2010 | 4 | 96 | 0 | 5 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 3 | 82 | 0 | 3 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 5 | 135 | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 143 | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 3 | 87 | 0 | — |
What is it indicated for?
FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210115: FiteBac CC OrthoSeal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210115
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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