510(k) · Cleared
ClearedPmma Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huliang (Shanghai) Bio-Tech Co., Ltd. · EBG Crown And Bridge, Temporary, Resin
Cleared on May 12, 2023 as substantially equivalent to K201683 (Huge Dental Material Co., Ltd., 2020) after a 151-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- May 12, 2023
- Review
- 151 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924830 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 4 generations backK060293 Temporary Crown and Bridge MaterialDentsply International, Inc. · 2006
- 3 generations backK071548 Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007
- 2 generations backK150432 Idodentine Disc, Idodentine BlockUnion Dental S.A. · 2015
- 1 generation backK201683 PMMA BlockHuge Dental Material Co., Ltd. · 2020
- This deviceK223706 Pmma BlockHuliang (Shanghai) Bio-Tech Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253380 “FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −4 | K060293 | Temporary Crown and Bridge Material | Dentsply International, Inc. | 2006 | — |
| −3 | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | Merz Dental GmbH | 2007 | — |
| −2 | K150432 | Idodentine Disc, Idodentine Block | Union Dental S.A. | 2015 | — |
| −1 | K201683 | PMMA Block | Huge Dental Material Co., Ltd. | 2020 | — |
| 0 (this device) | K223706 | Pmma Block | Huliang (Shanghai) Bio-Tech Co., Ltd. | 2023 | — |
| +1 | K253380 | “FLNT Base” and “FLNT Temp” | Liaoning Upcera Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 generations · 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 |
|---|---|---|---|
| * | K201683 | PMMA BlockSummary page 5…Device Trade Name 510 (k) No. Product Code Predicate HUGE DENTAL PMMA BLOCK K201683 EBG, EBI, MQC Primary MATERIAL CO., LTD. This predicate device has not been subject to a design-r… | 2020 |
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 |
|---|---|---|---|
| K253380 | “FLNT Base” and “FLNT Temp” | 2026 | 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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K253380 (Liaoning Upcera Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.
Indications for Use:
- Temporary anterior and posterior crowns;
- Temporary anterior and posterior bridges;
- Removable structures for dentures;
- Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223706 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223706: Pmma Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223706
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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