510(k) · Cleared
ClearedLight Cure Retainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Orthodontic Products, Inc. · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Oct 26, 2010 as substantially equivalent to K083051 (Reliance Orthodontic Products, Inc., 2009) after a 106-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Oct 26, 2010
- Review
- 106 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030951 (2003). 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 | K030951 | Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120P | Bisco, Inc. | 2003 | — |
| −1 | K083051 | Flowtain & Flowtain LV | Reliance Orthodontic Products, Inc. | 2009 | — |
| 0 (this device) | K101951 | Light Cure Retainer | Reliance Orthodontic Products, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K083051 | Flowtain & Flowtain LVSummary page 2…ion of occlusal buildups and for the retention of thermo-plastic aligners. 5.3 PREDICATE DEVICE: Reliance Orthodontic Products, Inc. Flowtain TM, 5 10(k) submission (K08305 1) dated 02/20/2009. Page IO Toll Free 1-800-323… | 2009 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K083051.
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. 2010, 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?
L.C.R. is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for the retention of thermo-plastic aligners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101951: Light Cure Retainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101951
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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