510(k) · Cleared
ClearedFlexible Block
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 Mar 4, 2022 as substantially equivalent to K150454 (Perflex, 2015) after a 73-day review. Its family tree reaches back 1 generation to 2015. 1 later device descends from it.
- Decided
- Mar 4, 2022
- Review
- 73 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K150454 (2015). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK150454 Acryfree Denture Base Material and Biosens Denture Base MaterialPerflex · 2015
- This deviceK213994 Flexible BlockShandong Huge Dental Material Corporation · 2022
- Descendant · cites it directly · 0 of its ownK250302 Flexible Partial ResinPrismatik Dentalcraft, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250302Flexible Partial ResinPrismatik Dentalcraft, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K150454 | Acryfree Denture Base Material and Biosens Denture Base Material | Perflex | 2015 | — |
| 0 (this device) | K213994 | Flexible Block | Shandong Huge Dental Material Corporation | 2022 | — |
| +1 | K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K150454 | Acryfree Denture Base Material and Biosens Denture Base MaterialSummary page 4…0 (k) NO. Equivalent (SE) Product code Decision Date PERFLEX Perflex Biosens K150454 05/26/2015 EBI, MQC This predicate device have not been subject to a design-related recall. 5. Descriptio… | 2015 |
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 |
|---|---|---|---|
| K250302 | Flexible Partial Resin | 2025 | 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?
- Its one ancestor has no recall.
- Of its descendants, K250302 (Prismatik Dentalcraft, Inc., 2025) has gone furthest, with 0 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. 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?
Intended for making dental plates, bite plates, frame-works, clasps,personal trays, appliances, occlusal splints and night guards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213994: Flexible Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213994
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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