510(k) · Cleared
ClearedOrtho-1(Not Finalized)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Feb 7, 2012 as substantially equivalent to K962946 (Bisco, Inc., 1996) and 2 other predicates after an 82-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Feb 7, 2012
- Review
- 82 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K875143 (1988). 5 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 | K875143 | Rely-a-Bond (NO Mix Orthodontic Adhesive) | Reliance Orthodontic Products, Inc. | 1988 | — |
| −1 | K962946 | Ortho-One | Bisco, Inc. | 1996 | — |
| 0 (this device) | K113401 | Ortho-1(Not Finalized) | Bisco, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K962946 | Ortho-OneSummary page 1…Class 11 per 21 CFR 872.3750 Predicate Devices: -- ~.-Ortho-1.is substantially-euiaeto Orh-One by Bisco, Inc. Schaumburg.1L-K962946;.- Light Bond (Quick Cure) by Reliance Orthodontic Products Inc., Itasca IL K00 1048: And Bisco Etchants by Bisco, Inc. S… | 1996 |
| * | K001048 | Light Bond (Quick Cure)Summary page 1…-- ~.-Ortho-1.is substantially-euiaeto Orh-One by Bisco, Inc. Schaumburg.1L-K962946;.- Light Bond (Quick Cure) by Reliance Orthodontic Products Inc., Itasca IL K00 1048: And Bisco Etchants by Bisco, Inc. Schaumburg IL K 10 1485. Indications for Use: The indication for use of Ortho-1I… | 2000 |
| * | K101485 | All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with…Summary page 1…Inc. Schaumburg.1L-K962946;.- Light Bond (Quick Cure) by Reliance Orthodontic Products Inc., Itasca IL K00 1048: And Bisco Etchants by Bisco, Inc. Schaumburg IL K 10 1485. Indications for Use: The indication for use of Ortho-1I is a bracket bonding system in the oral cavity of dental patie… | 2010 |
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 24 years and passes through 2 companies; a new generation was cleared every 15.4 years on median.
- None of the 5 ancestors has a recall.
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. 2012, 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?
The indication for use of Ortho-1 is a bracket bonding system in the oral cavity of dental patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113401: Ortho-1(Not Finalized).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113401
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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