510(k) · Cleared
ClearedTokuyama Sofreliner Tough
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 May 29, 2003 as substantially equivalent to K982537 (Tokuyama America, Inc., 1998) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- May 29, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K953589 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K112445Sofreliner Tough STokuyama Dental Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953589 | Tokuyama Soft Relining | Tokuyama America, Inc. | 1996 | — |
| 0 (this device) | K030663 | Tokuyama Sofreliner Tough | Tokuyama Dental Corporation | 2003 | — |
| +1 | K112445 | Sofreliner Tough S | Tokuyama Dental Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982537 | Tokuyama SofrelinerSummary page 1…according t o directions. It is substantially equivalent t o var ous marketed denture relining products, including the following: To kuyama Softrelininer (K982537) Tokuyama Soft Relining (K953589) GC Reline (K990736) Ccle Soft (K940566) Thc! Use of the pro… | 1998 |
| * | K953589 | Tokuyama Soft ReliningSummary page 1…ly equivalent t o var ous marketed denture relining products, including the following: To kuyama Softrelininer (K982537) Tokuyama Soft Relining (K953589) GC Reline (K990736) Ccle Soft (K940566) Thc! Use of the product is contra-indicated for patients w h o… | 1996 |
| * | K990736 | GC Reline Soft/Extra SoftSummary page 1…arketed denture relining products, including the following: To kuyama Softrelininer (K982537) Tokuyama Soft Relining (K953589) GC Reline (K990736) Ccle Soft (K940566) Thc! Use of the product is contra-indicated for patients w h o are sensitive t o silicone… | 1999 |
| Kept off the family tree | K940566 | Clea Soft Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…cts, including the following: To kuyama Softrelininer (K982537) Tokuyama Soft Relining (K953589) GC Reline (K990736) Ccle Soft (K940566) Thc! Use of the product is contra-indicated for patients w h o are sensitive t o silicone based products. L === Pa… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112445 | Sofreliner Tough S | 2011 | 0 |
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?
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.
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?
For use as a denture reliner
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030663: Tokuyama Sofreliner Tough.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030663
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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