510(k) · Cleared
ClearedFUJI I
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 Apr 13, 1998 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 13, 1998
- Review
- 49 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK980695 FUJI IGC America, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK101869 Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Silmet, Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK210473 Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova…Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2021
- Descendant · 2 generations on · 0 of its ownK200555 Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior…Prevest Denpro Limited · 2021
- Descendant · cites it directly · 0 of its ownK161851 Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK123824 Vitro Fil LCDfl Industria E Comercio SA · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101869Proglass Cements (One, Two Two LC, Nine, Plus, Silver)Silmet, Ltd. · 2010 · cites it directly3descendants
- K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass…Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · 2021 · 2 generations on0descendants
- K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior…Prevest Denpro Limited · 2021 · 2 generations on0descendants
- K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation · 2016 · cites it directly0descendants
- K123824Vitro Fil LCDfl Industria E Comercio SA · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980695 | FUJI I | GC America, Inc. | 1998 | — |
| +1 | K101869 | Proglass Cements (One, Two Two LC, Nine, Plus, Silver) | Silmet, Ltd. | 2010 | — |
| +2 | K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF… | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021 | — |
| +2 | K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron… | Prevest Denpro Limited | 2021 | — |
| +1 | K161851 | Glass Ionomer Cement (Luting) | Shandong Huge Dental Material Corporation | 2016 | — |
| +2 | K123824 | Vitro Fil LC | Dfl Industria E Comercio SA | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 2 | 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? (6)
3 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, K101869 (Silmet, Ltd., 2010) has gone furthest, with 3 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?
Fuji I is a self-cure glass ionomer material intended for the use as a luting cement for cementation of inlays, crowns, bridges and orthodontic bands.
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/K980695 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980695: FUJI I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980695
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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