510(k) · Cleared
ClearedPmma Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rizhao Huge Dental Industry Co., Ltd. · EBG Crown And Bridge, Temporary, Resin
Cleared on Feb 9, 2015 as substantially equivalent to K131664 (White Peaks Dental Systems GmbH & Co. KG, 2013) after a 255-day review. Its family tree reaches back 4 generations to 2007. 2 later devices descend from it.
- Decided
- Feb 9, 2015
- Review
- 255 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K070991 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- 3 generations backK080182 Zeno Pmma DiscWieland Dental + Technik GmbH & Co. KG · 2008
- 2 generations backK122025 Brightglass Brightglass MKtk Medical Supplies GmbH · 2012
- 1 generation backK131664 Copra Temp Pmma-DiskWhite Peaks Dental Systems GmbH & Co. KG · 2013
- This deviceK141421 Pmma BlockRizhao Huge Dental Industry Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK190217 Aidite PMMAAidite (Qinhuangdao) Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK223477 PMMA Blocks for Dental UseAidite (Qinhuangdao) Technology Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| −3 | K080182 | Zeno Pmma Disc | Wieland Dental + Technik GmbH & Co. KG | 2008 | — |
| −2 | K122025 | Brightglass Brightglass M | Ktk Medical Supplies GmbH | 2012 | — |
| −1 | K131664 | Copra Temp Pmma-Disk | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
| 0 (this device) | K141421 | Pmma Block | Rizhao Huge Dental Industry Co., Ltd. | 2015 | — |
| +1 | K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020 | — |
| +2 | K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K131664 | Copra Temp Pmma-DiskSummary page 4…Product Code: EBG · Predicate Device: CORPA TEMP PMMA-DISK submitted by WHITE PEAKS DENTAL SYSTEMS GMBH & CO.KG; K Number: K131664 · Device Description: This product is a kind of homogeneous high polymer material made from quality polymethylmethacrylate added… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190217 | Aidite PMMA | 2020 | 1 |
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 8 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K190217 (Aidite (Qinhuangdao) Technology Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K131664.
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. 2015, 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 a device 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141421: Pmma Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141421
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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