510(k) · Cleared
ClearedNew Stetic Acrylics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Stetic · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Mar 28, 2011 as substantially equivalent to K970522 (Austenal, Inc., 1997) after a 179-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Mar 28, 2011
- Review
- 179 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970522 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970522 Myerson's Economy Denture Base MaterialAustenal, Inc. · 1997
- This deviceK102874 New Stetic AcrylicsNew Stetic · 2011
- Descendant · cites it directly · 2 of its ownK131036 Yamahachi Denture Base ResinsYamahachi Dental Manufacturing Co. · 2013
- Descendant · 2 generations on · 0 of its ownK233859 Basis Flow IIYAMAHACHI DENTAL MFG., Co. · 2024
- Descendant · 2 generations on · 0 of its ownK143265 Acrylic BlockSun Medical Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK113788 Deflex AcrilatoNuxen S.R.L. · 2012
Most influential descendants
Showing 4 of 4 · See all- K131036Yamahachi Denture Base ResinsYamahachi Dental Manufacturing Co. · 2013 · cites it directly2descendants
- K233859Basis Flow IIYAMAHACHI DENTAL MFG., Co. · 2024 · 2 generations on0descendants
- K143265Acrylic BlockSun Medical Co., Ltd. · 2015 · 2 generations on0descendants
- K113788Deflex AcrilatoNuxen S.R.L. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970522 | Myerson's Economy Denture Base Material | Austenal, Inc. | 1997 | — |
| 0 (this device) | K102874 | New Stetic Acrylics | New Stetic | 2011 | — |
| +1 | K131036 | Yamahachi Denture Base Resins | Yamahachi Dental Manufacturing Co. | 2013 | — |
| +2 | K233859 | Basis Flow II | YAMAHACHI DENTAL MFG., Co. | 2024 | — |
| +2 | K143265 | Acrylic Block | Sun Medical Co., Ltd. | 2015 | — |
| +1 | K113788 | Deflex Acrilato | Nuxen S.R.L. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K970522 | Myerson's Economy Denture Base MaterialSummary page 1…stem consisting of monomerand polymer powder and liquid components. Predicate Device: K970522- Myersons Economy Denture Base Material. Substantial Equivalence: New Stetic claims… | 1997 |
What descends from it? (4)
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?
- Its one ancestor has no recall.
- Of its descendants, K131036 (Yamahachi Dental Manufacturing Co., 2013) has gone furthest, with 2 descendants of its own.
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. 2011, 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 indication for use of the New Stetic® Acrtylics is for the repair or fabrication of the denture base.
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/K102874 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102874: New Stetic Acrylics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102874
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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