510(k) · Cleared
ClearedZeno Pmma Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wieland Dental + Technik GmbH & Co. KG · EBG Crown And Bridge, Temporary, Resin
Cleared on Apr 8, 2008 as substantially equivalent to K070991 (Vita, 2007) after a 74-day review. Its family tree reaches back 1 generation to 2007. 9 later devices descend from it.
- Decided
- Apr 8, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070991 (2007). 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- This deviceK080182 Zeno Pmma DiscWieland Dental + Technik GmbH & Co. KG · 2008
- Descendant · cites it directly · 6 of its ownK122025 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 · cites it directly · 1 of its ownK112967 Pmma Cad/Cam DiscPolident D.O.O., Dental Products Industry · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K122025Brightglass Brightglass MKtk Medical Supplies GmbH · 2012 · cites it directly6descendants
- 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
- K112967Pmma Cad/Cam DiscPolident D.O.O., Dental Products Industry · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| 0 (this device) | K080182 | Zeno Pmma Disc | Wieland Dental + Technik GmbH & Co. KG | 2008 | — |
| +1 | 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 | — |
| +1 | K112967 | Pmma Cad/Cam Disc | Polident D.O.O., Dental Products Industry | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202…Summary page 1…StraBe 13 75179 Plorzheim, Germany Pustfach 102040 75120 Pforzheim, Germany fon +49 723173705 ¢ lax +49 /231/357959 VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4 K 070991 Page 5-1 WIELAND Dental +Technik… | 2007 |
What descends from it? (9)
3 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?
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. 2008, 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?
ZENO®PMMA Discs are milling blanks consisting of polymethylmethacrylate. They are designed for
making long-term temporary crown and bridge work and have to be machined with the CAD/CAM
technique. ZENO PMMA Discs are recommended for manufacturing substructures of single tooth and
bridgework with one or two pontics.
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/K080182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080182: Zeno Pmma Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080182
Report an extraction error
Are you the manufacturer?
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