510(k) · Cleared
ClearedOptiglaze Color
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 Mar 6, 2014 as substantially equivalent to K052462 (GC America, Inc., 2005) after a 78-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it.
- Decided
- Mar 6, 2014
- Review
- 78 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052462 (2005). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK052462 G-COATGC America, Inc. · 2005
- This deviceK133836 Optiglaze ColorGC America, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK254091 Glossy Coat (15ML)YAMAHACHI DENTAL MFG., Co. · 2026
- Descendant · cites it directly · 0 of its ownK250804 ID Light Cure SystemId Korea Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240735 visio.lign color, visio.lign shieldBredent GmbH & Co. KG · 2024
- Descendant · cites it directly · 0 of its ownK153325 Gradia PlusGC America, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K254091Glossy Coat (15ML)YAMAHACHI DENTAL MFG., Co. · 2026 · cites it directly0descendants
- K250804ID Light Cure SystemId Korea Co., Ltd. · 2025 · cites it directly0descendants
- K240735visio.lign color, visio.lign shieldBredent GmbH & Co. KG · 2024 · cites it directly0descendants
- K153325Gradia PlusGC America, Inc. · 2016 · cites it directly0descendants
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) | K133836 | Optiglaze Color | GC America, Inc. | 2014 | — |
| +1 | K254091 | Glossy Coat (15ML) | YAMAHACHI DENTAL MFG., Co. | 2026 | — |
| +1 | K250804 | ID Light Cure System | Id Korea Co., Ltd. | 2025 | — |
| +1 | K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | 2024 | — |
| +1 | K153325 | Gradia Plus | GC America, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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…Coman Device 1510(k) No. IDale Cleared GC America Inc. 0-Coat K052462 1 0/20/05 4. Description of Device: 5. Optiglaze Color is a light-cured glazing and for characterization of direct and… | 2005 |
What descends from it? (4)
4 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?
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
1. For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth.
2. For obtaining surface smoothness and wear resistance of restorations made of composite-resin, acrylic denture base and artificial acrylic teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133836: Optiglaze Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133836
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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