510(k) · Cleared
ClearedFuji Vii Capsule
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 Oct 29, 2001 after a 34-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Oct 29, 2001
- Review
- 34 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK013198 Fuji Vii CapsuleGC America, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK073395 Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008
- Descendant · 2 generations on · 2 of its ownK091632 SPK Sealant3M Company · 2009
- Descendant · 3 generations on · 1 of its ownK100062 Infiltration KitDmg USA, Inc. · 2010
- Descendant · 4 generations on · 0 of its ownK251124 G-Bond UniversalGC America, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK193484 GC Fuji Triage EPGC America, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K073395Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008 · cites it directly3descendants
- K091632SPK Sealant3M Company · 2009 · 2 generations on2descendants
- K100062Infiltration KitDmg USA, Inc. · 2010 · 3 generations on1descendant
- K251124G-Bond UniversalGC America, Inc. · 2025 · 4 generations on0descendants
- K193484GC Fuji Triage EPGC America, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013198 | Fuji Vii Capsule | GC America, Inc. | 2001 | — |
| +1 | K073395 | Gilb-2, Glass Ionomer Protective Coating | 3M Espe Dental Products | 2008 | — |
| +2 | K091632 | SPK Sealant | 3M Company | 2009 | — |
| +3 | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| +4 | K251124 | G-Bond Universal | GC America, Inc. | 2025 | — |
| +1 | K193484 | GC Fuji Triage EP | GC America, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2020 | 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? (5)
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, K073395 (3M Espe Dental Products, 2008) 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?
GC Fuji VII is a capsulated restorative glass jonomer cement intended for :
Treatment of early non-cavitated lcsions; such as tooth brush abrasion and Root surface senditivity.
Pit and Fissure Sealant
Intermediate Trestorative material
Temporary filling of endodontic access
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/K013198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013198: Fuji Vii Capsule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013198
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026