510(k) · Cleared
ClearedGC Ortho Connect, GC Ortho Etching Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gc Orthodontics America, Inc. · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Jul 16, 2015 after a 177-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 16, 2015
- Review
- 177 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK150128 GC Ortho Connect, GC Ortho Etching GelGc Orthodontics America, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK261129 OrthoFitSpident Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261129OrthoFitSpident Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K150128 | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | 2015 | — |
| +1 | K261129 | OrthoFit | Spident Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261129 | OrthoFit | 2026 | 0 |
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?
- Of its descendants, K261129 (Spident Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
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. 2015, 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?
GC Ortho Connect
1. Bonding metal brackets and attachments
2. Bonding ceramic brackets
3. Bonding plastic brackets and acrylic appliances
GC Ortho Etching Gel
1. Etching enamel of tooth surfaces
2. Enhancing the bond strength of light-cured orthodontic adhesive materials
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K150128 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150128: GC Ortho Connect, GC Ortho Etching Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150128
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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