510(k) · Cleared
ClearedFlowtain & Flowtain LV
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 Feb 20, 2009 as substantially equivalent to K073697 (3M Unitek, 2008) and 1 other predicate after a 129-day review. Its family tree reaches back 1 generation to 2003. 5 later devices descend from it.
- Decided
- Feb 20, 2009
- Review
- 129 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K030951 (2003). 2 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK030951 Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120PBisco, Inc. · 2003
- This deviceK083051 Flowtain & Flowtain LVReliance Orthodontic Products, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK234043 3M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products · 2023
- Descendant · cites it directly · 0 of its ownK130237 Pontic PaintReliance Orthodontic Products, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK123348 Clear Aligner AdhesiveReliance Orthodontic Products, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK101951 Light Cure RetainerReliance Orthodontic Products, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK100301 Opal Bond FlowUltradent Products, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products · 2023 · cites it directly0descendants
- K130237Pontic PaintReliance Orthodontic Products, Inc. · 2013 · cites it directly0descendants
- K123348Clear Aligner AdhesiveReliance Orthodontic Products, Inc. · 2013 · cites it directly0descendants
- K101951Light Cure RetainerReliance Orthodontic Products, Inc. · 2010 · cites it directly0descendants
- K100301Opal Bond FlowUltradent Products, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030951 | Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120P | Bisco, Inc. | 2003 | — |
| 0 (this device) | K083051 | Flowtain & Flowtain LV | Reliance Orthodontic Products, Inc. | 2009 | — |
| +1 | K234043 | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | 2023 | — |
| +1 | K130237 | Pontic Paint | Reliance Orthodontic Products, Inc. | 2013 | — |
| +1 | K123348 | Clear Aligner Adhesive | Reliance Orthodontic Products, Inc. | 2013 | — |
| +1 | K101951 | Light Cure Retainer | Reliance Orthodontic Products, Inc. | 2010 | — |
| +1 | K100301 | Opal Bond Flow | Ultradent Products, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K073697 | Transbond Supreme AdhesiveSummary page 2…cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets. 5.3 PREDICATE DEVICE: 3M Unitek Transbond Tm Supreme LV, 510(k) submission (K073 697) dated 02/15/2008 for intended use. FlowtainTM and Flowtain Tm LV are similar in composition as Bisco Inc. TESCERAFLO Tm , 510(k)… | 2008 |
| * | K030951 | Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120PSummary page 2…510(k) submission (K073 697) dated 02/15/2008 for intended use. FlowtainTM and Flowtain Tm LV are similar in composition as Bisco Inc. TESCERAFLO Tm , 510(k) submission (K03095 1) for safety and performance. Page 10 Toll Free 1-800… | 2003 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2009, 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?
FlowtainTM 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 and splinting materials, creation of archwire stops and indirect bonding of orthodontic brackets. FlowtainTM can also be used for the retention of thermoplastic aligners.
FlowtainTm LV is a lower viscosity, flowable light cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083051: Flowtain & Flowtain LV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083051
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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