510(k) · Cleared
ClearedThermeo® I Msi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro3Dure Medical GmbH · MQC Mouthguard, Prescription
Cleared on Sep 29, 2026 as substantially equivalent to K212017 (Pro3Dure Medical GmbH, 2022) after a 266-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Sep 29, 2026
- Review
- 266 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924830 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 6 generations backK060293 Temporary Crown and Bridge MaterialDentsply International, Inc. · 2006
- 5 generations backK071548 Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007
- 4 generations backK150432 Idodentine Disc, Idodentine BlockUnion Dental S.A. · 2015
- 3 generations backK180578 Harvest Dental Polymer BlocksHarvest Dental Products, LLC · 2018
- 2 generations backK192153 Portux CAD/CAM DiscNew Stetic, SA · 2019
- 1 generation backK212017 Thermeo SystemPro3Dure Medical GmbH · 2022
- This deviceK260031 Thermeo® I MsiPro3Dure Medical GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −6 | K060293 | Temporary Crown and Bridge Material | Dentsply International, Inc. | 2006 | — |
| −5 | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | Merz Dental GmbH | 2007 | — |
| −4 | K150432 | Idodentine Disc, Idodentine Block | Union Dental S.A. | 2015 | — |
| −3 | K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | 2018 | — |
| −2 | K192153 | Portux CAD/CAM Disc | New Stetic, SA | 2019 | — |
| −1 | K212017 | Thermeo System | Pro3Dure Medical GmbH | 2022 | — |
| 0 (this device) | K260031 | Thermeo® I Msi | Pro3Dure Medical GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 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 MQC? 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 MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.3 · 5 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 |
|---|---|---|---|
| * | K212017 | Thermeo SystemSummary page 5…@kontoudisconsulting.com Date Prepared January 5, 2026 Classification Unclassified Product Code MQC Predicate Device Thermeo System (K212017) Reference Device GR Resin System MSI (K231775) Indications for Use: The THERMEO® I MSI blank is a disc intended for th… | 2022 |
| † | K231775 | GR Resin System MSI | 2024 |
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 32 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, 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 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The THERMEO® | MSI blank is a disc intended for the fabrication of dental appliances such as mouthguards, nightguards, bruxism and TMJ splint appliances, and bite splints using CAD/CAM milling machines.
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/K260031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260031: Thermeo® I Msi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260031
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026