510(k) · Cleared
ClearedOrmco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corporation · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Jan 3, 2025 as substantially equivalent to K941015 (Ormco Corp., 1994) and 2 other predicates after a 1-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jan 3, 2025
- Review
- 1 day
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K900510 (1990). 38 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 7 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 6 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 5 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 4 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 3 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 2 generations backK071131 UNO3M Espe AG Dental Products · 2007
- 1 generation backK110302 Adhesive Exl-7593M Espe AG · 2011
- This deviceK250015 Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer…Ormco Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −6 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −5 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −4 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −3 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| −1 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| 0 (this device) | K250015 | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™… | Ormco Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K941015 | Ormco System 1+ (TM)Summary page 4…872.3750 Product Code(s) DYH | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K941015 Ormco Etching Solution DYH K110302 3M Scotchbond Universal KLE K880393 3M Unitek Transbond XT Light Cure Paste Adhesive DYH Devic… | 1994 |
| * | K110302 | Adhesive Exl-759Summary page 4…gally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K941015 Ormco Etching Solution DYH K110302 3M Scotchbond Universal KLE K880393 3M Unitek Transbond XT Light Cure Paste Adhesive DYH Device Description Summary 21 CFR 807.92… | 2011 |
| * | K880393 | Transbond Light Cured Orthodontic AdhesiveSummary page 4…CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K941015 Ormco Etching Solution DYH K110302 3M Scotchbond Universal KLE K880393 3M Unitek Transbond XT Light Cure Paste Adhesive DYH Device Description Summary 21 CFR 807.92(a)(4) The Ormco™ Bonding System co… | 1988 |
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 35 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 38 ancestors has a recall of any class.
- 1 other device also cites its predicate K941015.
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. 2025, 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?
Ormco™ EtchFree Bonding Primer is a bonding primer intended to bond orthodontic appliances such as metal brackets, ceramic brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco’s Ortho Solo™ and an adhesive/cement without etching.
Ormco™ EtchFree Adhesive is a light-curing orthodontic bonding adhesive that is intended to be used for the attachment of orthodontic appliances to teeth such as metal bracket, ceramic brackets, and aligner attachments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250015: Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250015
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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