510(k) · Cleared
ClearedPortux CAD/CAM Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Stetic, SA · EBG Crown And Bridge, Temporary, Resin
Cleared on Nov 7, 2019 as substantially equivalent to K180578 (Harvest Dental Products, LLC, 2018) after a 90-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 7, 2019
- Review
- 90 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. 2 later devices descend 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 backK180578 Harvest Dental Polymer BlocksHarvest Dental Products, LLC · 2018
- This deviceK192153 Portux CAD/CAM DiscNew Stetic, SA · 2019
- Descendant · cites it directly · 1 of its ownK212017 Thermeo SystemPro3Dure Medical GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK260031 Thermeo® I MsiPro3Dure Medical GmbH · 2026
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 |
|---|---|---|---|---|---|
| −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 | K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | 2018 | — |
| 0 (this device) | K192153 | Portux CAD/CAM Disc | New Stetic, SA | 2019 | — |
| +1 | K212017 | Thermeo System | Pro3Dure Medical GmbH | 2022 | — |
| +2 | K260031 | Thermeo® I Msi | Pro3Dure Medical GmbH | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K180578 | Harvest Dental Polymer BlocksSummary page 4…s to the following Primary Predicate device: 510(k) Primary Predicate Device Name Company Name K180578 Harvest Dental Polymer Blocks Harvest Dental Products, LLC 5.4 DEVICE DESCRIPTION T… | 2018 |
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 |
|---|---|---|---|
| K212017 | Thermeo System | 2022 | 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 25 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K212017 (Pro3Dure Medical GmbH, 2022) has gone furthest, with 1 descendant 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. 2019, 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?
For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.
- Provisional anterior and posterior crowns & bridges
- Implant and abutment supported prosthetics.
- Partial, complete and hybrid denture prosthetics (base and teeth) — Removable appliances (splint)
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/K192153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192153: Portux CAD/CAM Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192153
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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