510(k) · Cleared
ClearedEasy Glaze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voco GmbH · EBD Coating, Filling Material, Resin
Cleared on Oct 24, 2008 as substantially equivalent to K052462 (GC America, Inc., 2005) after a 74-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Oct 24, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052462 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK052462 G-COATGC America, Inc. · 2005
- This deviceK082285 Easy GlazeVoco GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052462 | G-COAT | GC America, Inc. | 2005 | — |
| 0 (this device) | K082285 | Easy Glaze | Voco GmbH | 2008 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K052462 | G-COATSummary page 1…liners/build-ip restorations before taking impressions Technological characteristics: All of the components of EASY GLAZE are found in the legally marketed devices K052462 (G-Coat, the predicate device), K043168 (Biscover LV, Bisco, Inc.) K974772 (Ufi Gel SC, VOCO GmbH) and K070306 (Paint-on Polish A… | 2005 |
| † | K043168 | Biscover LV | 2005 |
| † | K974772 | Ufi Gel C | 1998 |
| † | K070306 | Paint- on Polish Agent | 2007 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K052462.
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
EASY GLAZE is intended for the following applications:
1. Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
2. Sealing the adhesive interfaces between restoration and tooth structure.
3. Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
4. Sealing glass ionomer cement liners/build-up restorations before taking impressions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082285: Easy Glaze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082285
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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