510(k) · Cleared
ClearedBrightglass Brightglass M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ktk Medical Supplies GmbH · EBG Crown And Bridge, Temporary, Resin
Cleared on Oct 9, 2012 as substantially equivalent to K080182 (Wieland Dental + Technik GmbH & Co. KG, 2008) after a 90-day review. Its family tree reaches back 2 generations to 2007. 6 later devices descend from it.
- Decided
- Oct 9, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070991 (2007). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- 1 generation backK080182 Zeno Pmma DiscWieland Dental + Technik GmbH & Co. KG · 2008
- This deviceK122025 Brightglass Brightglass MKtk Medical Supplies GmbH · 2012
- Descendant · cites it directly · 4 of its ownK131664 Copra Temp Pmma-DiskWhite Peaks Dental Systems GmbH & Co. KG · 2013
- Descendant · 2 generations on · 2 of its ownK141421 Pmma BlockRizhao Huge Dental Industry Co., Ltd. · 2015
- Descendant · 3 generations on · 1 of its ownK190217 Aidite PMMAAidite (Qinhuangdao) Technology Co., Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK223477 PMMA Blocks for Dental UseAidite (Qinhuangdao) Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK152443 Vericore Gradient Temporary DiscWhip Mix Corporation · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131664Copra Temp Pmma-DiskWhite Peaks Dental Systems GmbH & Co. KG · 2013 · cites it directly4descendants
- K141421Pmma BlockRizhao Huge Dental Industry Co., Ltd. · 2015 · 2 generations on2descendants
- K190217Aidite PMMAAidite (Qinhuangdao) Technology Co., Ltd. · 2020 · 3 generations on1descendant
- K223477PMMA Blocks for Dental UseAidite (Qinhuangdao) Technology Co., Ltd. · 2023 · 4 generations on0descendants
- K152443Vericore Gradient Temporary DiscWhip Mix Corporation · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| −1 | K080182 | Zeno Pmma Disc | Wieland Dental + Technik GmbH & Co. KG | 2008 | — |
| 0 (this device) | K122025 | Brightglass Brightglass M | Ktk Medical Supplies GmbH | 2012 | — |
| +1 | K131664 | Copra Temp Pmma-Disk | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
| +2 | K141421 | Pmma Block | Rizhao Huge Dental Industry Co., Ltd. | 2015 | — |
| +3 | K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020 | — |
| +4 | K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023 | — |
| +2 | K152443 | Vericore Gradient Temporary Disc | Whip Mix Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K080182 | Zeno Pmma DiscSummary page 1…wn and Bridge Resin CODR. section number 872.3770 Product Code EBG Regulatory Class class 11 Predicate Devices K0801 82 ZENO PMMA Discs Device Description BRIGHTGLASS discs are milling blanks composed of… | 2008 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131664 (White Peaks Dental Systems GmbH & Co. KG, 2013) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K080182.
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. 2012, 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?
BRIGHTGLASS Discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined with the CAD/CAM technique.
BRIGHTGLASS Discs are recommended for manufactuing substructures of single tooth crowns and bridgework with up to two pontics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122025: Brightglass Brightglass M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122025
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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