510(k) · Cleared
ClearedG-COAT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EBD Coating, Filling Material, Resin
Cleared on Oct 20, 2005 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Oct 20, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK052462 G-COATGC America, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK133836 Optiglaze ColorGC America, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK254091 Glossy Coat (15ML)YAMAHACHI DENTAL MFG., Co. · 2026
- Descendant · 2 generations on · 0 of its ownK250804 ID Light Cure SystemId Korea Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK240735 visio.lign color, visio.lign shieldBredent GmbH & Co. KG · 2024
- Descendant · 2 generations on · 0 of its ownK153325 Gradia PlusGC America, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133836Optiglaze ColorGC America, Inc. · 2014 · cites it directly4descendants
- K254091Glossy Coat (15ML)YAMAHACHI DENTAL MFG., Co. · 2026 · 2 generations on0descendants
- K250804ID Light Cure SystemId Korea Co., Ltd. · 2025 · 2 generations on0descendants
- K240735visio.lign color, visio.lign shieldBredent GmbH & Co. KG · 2024 · 2 generations on0descendants
- K153325Gradia PlusGC America, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052462 | G-COAT | GC America, Inc. | 2005 | — |
| +1 | K133836 | Optiglaze Color | GC America, Inc. | 2014 | — |
| +2 | K254091 | Glossy Coat (15ML) | YAMAHACHI DENTAL MFG., Co. | 2026 | — |
| +2 | K250804 | ID Light Cure System | Id Korea Co., Ltd. | 2025 | — |
| +2 | K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | 2024 | — |
| +2 | K153325 | Gradia Plus | GC America, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 EBD? 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 EBD device
- #1 K254091 Glossy Coat (15ML)score 11.4 · 2 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? (6)
2 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?
- Of its descendants, K133836 (GC America, Inc., 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBD
76in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBD
No recall names EBD since 2007.
Adverse event reports per year · EBD
5in 2023
MAUDE reports naming product code EBD, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 76 | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
To seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations,
provisional restorations and their adhesive interface of margin to enamel or dentin.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052462: G-COAT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052462
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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