510(k) · Cleared
ClearedFuji II LC Capsule
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 Jan 11, 2000 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Jan 11, 2000
- Review
- 49 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK993973 Fuji II LC CapsuleGC America, Inc. · 2000
- Descendant · cites it directly · 6 of its ownK052235 LCR3M Company · 2005
- Descendant · cites it directly · 5 of its ownK123265 Rmgi Low ViscosityPulpdent Corporation · 2012
- Descendant · 2 generations on · 4 of its ownK130223 Rmgi FillPulpdent Corporation · 2013
- Descendant · 3 generations on · 1 of its ownK153249 Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016
- Descendant · 3 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- K052235LCR3M Company · 2005 · cites it directly6descendants
- K123265Rmgi Low ViscosityPulpdent Corporation · 2012 · cites it directly5descendants
- K130223Rmgi FillPulpdent Corporation · 2013 · 2 generations on4descendants
- K153249Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016 · 3 generations on1descendant
- K250953Equia LC OneGC America, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993973 | Fuji II LC Capsule | GC America, Inc. | 2000 | — |
| +1 | K052235 | LCR | 3M Company | 2005 | — |
| +1 | K123265 | Rmgi Low Viscosity | Pulpdent Corporation | 2012 | — |
| +2 | K130223 | Rmgi Fill | Pulpdent Corporation | 2013 | — |
| +3 | K153249 | Pulpdent Solo Flowable Composite with MCP | Pulpdent Corporation | 2016 | — |
| +3 | K250953 | Equia LC One | GC America, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
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, K052235 (3M Company, 2005) has gone furthest, with 6 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.
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?
a. Class III and V restorations; particularly areas of cervical erosion,
abfraction lesions and root surface caries.
b. Restoration of primary teeth
c. As a base or liner
d. Core build-ups/block-outs (particularly of vital teeth)
e. Cases in which a radiopaque restoration is required
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993973: Fuji II LC Capsule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993973
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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