510(k) · Cleared
ClearedPMMA Blocks for Dental Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aidite (Qinhuangdao) Technology Co., Ltd. · EBG Crown And Bridge, Temporary, Resin
Cleared on Feb 16, 2023 as substantially equivalent to K190217 (Aidite (Qinhuangdao) Technology Co., Ltd., 2020) after a 90-day review. Its family tree reaches back 6 generations to 2007.
- Decided
- Feb 16, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K070991 (2007). No later device cites it as a predicate yet.
- Root · 6 generations backK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- 5 generations backK080182 Zeno Pmma DiscWieland Dental + Technik GmbH & Co. KG · 2008
- 4 generations backK122025 Brightglass Brightglass MKtk Medical Supplies GmbH · 2012
- 3 generations backK131664 Copra Temp Pmma-DiskWhite Peaks Dental Systems GmbH & Co. KG · 2013
- 2 generations backK141421 Pmma BlockRizhao Huge Dental Industry Co., Ltd. · 2015
- 1 generation backK190217 Aidite PMMAAidite (Qinhuangdao) Technology Co., Ltd. · 2020
- This deviceK223477 PMMA Blocks for Dental UseAidite (Qinhuangdao) Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| −5 | K080182 | Zeno Pmma Disc | Wieland Dental + Technik GmbH & Co. KG | 2008 | — |
| −4 | K122025 | Brightglass Brightglass M | Ktk Medical Supplies GmbH | 2012 | — |
| −3 | K131664 | Copra Temp Pmma-Disk | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
| −2 | K141421 | Pmma Block | Rizhao Huge Dental Industry Co., Ltd. | 2015 | — |
| −1 | K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K190217 | Aidite PMMASummary page 4…Regulation number: 21 CFR 872.3770 Classification: Class II Panel: Dental 3.0 Identification of Predicate Device and Reference Device 510(k) Number: K190217 (Primary Predicate) Product Name: Aidite Pmma Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd. This predicate has not bee… | 2020 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
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?
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223477: PMMA Blocks for Dental Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223477
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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