510(k) · Cleared
ClearedTokuyama Curegrace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokuyama Dental Corporation · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jul 5, 2017 as substantially equivalent to K984365 (GC America, Inc., 1999) after a 131-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jul 5, 2017
- Review
- 131 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984365 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK984365 GC Unifast TradGC America, Inc. · 1999
- This deviceK170549 Tokuyama CuregraceTokuyama Dental Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984365 | GC Unifast Trad | GC America, Inc. | 1999 | — |
| 0 (this device) | K170549 | Tokuyama Curegrace | Tokuyama Dental Corporation | 2017 | — |
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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K984365 | GC Unifast TradSummary page 7…ference device Device name TOKUYAMA CUREGRACE GC UNIFAST TRAD ONIFAST I Manufacturer Tokuyama Dental Corporation GC America Inc. GC America Inc. 510(K) number (Pending) K984365 K073106 Device classification name -~ Resin, denture, relining, repairing, rebasing - Crown and bridge, temporary, resin - Re… | 1999 |
| † | K073106 | Unifast Iii | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
The TOKUYAMA CUREGRACE device is an acrylic resin used in a variety of dental applications such as:
- Temporary inlay, crowns and bridges
- Repair of broken or cracked dentures
- Denture border extension.
- Replacement of lost denture teeth
- Adjustment of the occlusal height of resin teeth
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170549: Tokuyama Curegrace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170549
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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