510(k) · Cleared
ClearedDenture Base Polymers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Huge Dental Material Corporation · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Aug 12, 2022 as substantially equivalent to K102654 (Vertex-Dental B.V., 2010) and 1 other predicate after a 157-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Aug 12, 2022
- Review
- 157 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K901789 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK901789 Paladon (R) 65Kulzer, Inc. · 1990
- 2 generations backK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- 1 generation backK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- This deviceK220680 Denture Base PolymersShandong Huge Dental Material Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| −2 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| −1 | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| 0 (this device) | K220680 | Denture Base Polymers | Shandong Huge Dental Material Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K102654 | Vertex Rapid SimplifiedSummary page 4…Decision Date VERTEX-DENTAL Vertex Rapid Primary K102654 12/03/2010 EBI BV Simplified Predicate… | 2010 |
| * | K102640 | Vertex Self Curing, Vertex Castavaria, Vertex CastapressSummary page 4…Vertex Self Curing, VERTEX-DENTAL Secondary Vertex Castavaria, K102640 03/25/2011 EBI BV Predicate… | 2011 |
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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 11.7 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K102654.
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. 2022, 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?
Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220680 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220680: Denture Base Polymers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220680
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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