510(k) · Cleared
ClearedGCUC-505
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jul 22, 2009 as substantially equivalent to K042348 (GC America, Inc., 2004) and 2 other predicates after a 72-day review. Its family tree reaches back 1 generation to 2004. 43 later devices descend from it.
- Decided
- Jul 22, 2009
- Review
- 72 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K042819 (2004). 3 ancestors in all. 43 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- This deviceK091388 GCUC-505GC America, Inc. · 2009
- Descendant · cites it directly · 39 of its ownK123631 MFP-051GC America, Inc. · 2013
- Descendant · 2 generations on · 32 of its ownK133824 CerasmartGC America, Inc. · 2014
- Descendant · 3 generations on · 26 of its ownK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 4 generations on · 25 of its ownK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 5 generations on · 24 of its ownK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K123631MFP-051GC America, Inc. · 2013 · cites it directly39descendants
- K133824CerasmartGC America, Inc. · 2014 · 2 generations on32descendants
- K160425CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016 · 3 generations on26descendants
- K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016 · 4 generations on25descendants
- K201668VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| 0 (this device) | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| +1 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| +2 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| +3 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| +4 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| +5 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 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 |
|---|---|---|---|
| * | K042348 | Gradia Direct LofloSummary page 1…F Predicate Devices: Cormnny Device K Number Date Cleared I GC America Inc. GRADIA DIRECT LoFlo K042348 01130/2003 [GC America Inc. I GDLS-200 (Kalore) K082434 11114/2008 IvoclarVivadent, Inc.… | 2004 |
| * | K082434 | GDLS-200Summary page 1…mber Date Cleared I GC America Inc. GRADIA DIRECT LoFlo K042348 01130/2003 [GC America Inc. I GDLS-200 (Kalore) K082434 11114/2008 IvoclarVivadent, Inc. TETRIC EVOCERAM K042819 11/09/2004 Descriotion of Device: MI… | 2008 |
| * | K042819 | Tetric EvoceramSummary page 1…42348 01130/2003 [GC America Inc. I GDLS-200 (Kalore) K082434 11114/2008 IvoclarVivadent, Inc. TETRIC EVOCERAM K042819 11/09/2004 Descriotion of Device: MI Fil (GCUC-505) is a light-cured nano-filled radiopaque composite resin filled in a syr… | 2004 |
What descends from it? (43)
See all 436 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K123631 (GC America, Inc., 2013) has gone furthest, with 39 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Restoration of Class I, il, III, IV, V cavities
Restoration of root surface caries
Restorations in deciduous teeth
Filling tunnel shaped cavities
Sealing hypersensitive areas
Liner/base/filling in cavity undercuts
Sealant
Splinting mobile teeth
Additions to composite restorations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091388 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091388: GCUC-505.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091388
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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