510(k) · Cleared
ClearedGC Fuji Fil LC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EMA Cement, Dental
Cleared on Aug 22, 2005 after an 82-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Aug 22, 2005
- Review
- 82 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK051427 GC Fuji Fil LCGC America, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK123265 Rmgi Low ViscosityPulpdent Corporation · 2012
- Descendant · cites it directly · 4 of its ownK130223 Rmgi FillPulpdent Corporation · 2013
- Descendant · cites it directly · 1 of its ownK172382 GC Fuji DirectGC America, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK153249 Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK250953 Equia LC OneGC America, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K123265Rmgi Low ViscosityPulpdent Corporation · 2012 · cites it directly5descendants
- K130223Rmgi FillPulpdent Corporation · 2013 · cites it directly4descendants
- K172382GC Fuji DirectGC America, Inc. · 2018 · cites it directly1descendant
- K153249Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016 · 2 generations on1descendant
- K250953Equia LC OneGC America, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051427 | GC Fuji Fil LC | GC America, Inc. | 2005 | — |
| +1 | K123265 | Rmgi Low Viscosity | Pulpdent Corporation | 2012 | — |
| +1 | K130223 | Rmgi Fill | Pulpdent Corporation | 2013 | — |
| +1 | K172382 | GC Fuji Direct | GC America, Inc. | 2018 | — |
| +2 | K153249 | Pulpdent Solo Flowable Composite with MCP | Pulpdent Corporation | 2016 | — |
| +2 | K250953 | Equia LC One | GC America, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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? (8)
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?
- Of its descendants, K123265 (Pulpdent Corporation, 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
This product is a radiopaque light-cured reinforced glass ionomer restorative for use in
the following recommended indications:
1. Class III and V restorations, particularly for cervical erosions and root surface
caries.
2. Restoration of primary teeth
3. Core Build-up
4. Cases where radiopacity is required
5. As a base or a liner.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051427: GC Fuji Fil LC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051427
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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