510(k) · Cleared
ClearedYamahachi Denture Base Resins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yamahachi Dental Manufacturing Co. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jul 12, 2013 as substantially equivalent to K102874 (New Stetic, 2011) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Jul 12, 2013
- Review
- 88 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913655 (1991). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK913655 Probase Hot and Probase ColdIvoclar North America, Inc. · 1991
- 1 generation backK102640 Vertex Self Curing, Vertex Castavaria, Vertex CastapressVertex-Dental B.V. · 2011
- This deviceK131036 Yamahachi Denture Base ResinsYamahachi Dental Manufacturing Co. · 2013
- Descendant · cites it directly · 0 of its ownK233859 Basis Flow IIYAMAHACHI DENTAL MFG., Co. · 2024
- Descendant · cites it directly · 0 of its ownK143265 Acrylic BlockSun Medical Co., Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913655 | Probase Hot and Probase Cold | Ivoclar North America, Inc. | 1991 | — |
| −1 | K102640 | Vertex Self Curing, Vertex Castavaria, Vertex Castapress | Vertex-Dental B.V. | 2011 | — |
| 0 (this device) | K131036 | Yamahachi Denture Base Resins | Yamahachi Dental Manufacturing Co. | 2013 | — |
| +1 | K233859 | Basis Flow II | YAMAHACHI DENTAL MFG., Co. | 2024 | — |
| +1 | K143265 | Acrylic Block | Sun Medical Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K102874 | New Stetic AcrylicsSummary page 1…ase Polymer Classification Name: Denture Relining, Repairing, or Rebasing Resin Regulation Number: 872.3760 Product Code: EBI Regulatory Class: II Predicates K 102874 Veracril, Veracril H-L Ez-Cryl (New Stetic, Columbia) K 102640 Vertex Self-Curing, Vertex Castavaria (Vertex Dental… | 2011 |
| * | K102640 | Vertex Self Curing, Vertex Castavaria, Vertex CastapressSummary page 1…ing Resin Regulation Number: 872.3760 Product Code: EBI Regulatory Class: II Predicates K 102874 Veracril, Veracril H-L Ez-Cryl (New Stetic, Columbia) K 102640 Vertex Self-Curing, Vertex Castavaria (Vertex Dental, The Netherlands) 5-1… | 2011 |
What descends from it? (2)
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 19.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K233859 (YAMAHACHI DENTAL MFG., Co., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102874.
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. 2013, 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?
Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base.
All devices are sold by or on the order of aphysician. They are notfor use by the generalpublic or over-the-counter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131036: Yamahachi Denture Base Resins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131036
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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