510(k) · Cleared
ClearedThermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bernhard Förster GmbH · MQC Mouthguard, Prescription
Cleared on Aug 2, 2024 as substantially equivalent to K200125 (Erkodent Erich Kopp GmbH, 2020) after an 85-day review. Its family tree reaches back 5 generations to 1978.
- Decided
- Aug 2, 2024
- Review
- 85 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K780619 (1978). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 4 generations backK981095 Align SystemAlign Technology · 1998
- 3 generations backK062828 Mouthguard and Aligner MaterialsDentsply Intl., Inc. · 2006
- 2 generations backK072522 Thermoform Sheet Materials and AccessoriesDentsply International, Inc. · 2007
- 1 generation backK200125 Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH · 2020
- This deviceK241311 Thermoforming Sheet Materials (Track A); Thermoforming Sheet…Bernhard Förster GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −4 | K981095 | Align System | Align Technology | 1998 | — |
| −3 | K062828 | Mouthguard and Aligner Materials | Dentsply Intl., Inc. | 2006 | — |
| −2 | K072522 | Thermoform Sheet Materials and Accessories | Dentsply International, Inc. | 2007 | — |
| −1 | K200125 | Thermoforming Sheet Materials | Erkodent Erich Kopp GmbH | 2020 | — |
| 0 (this device) | K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track… | Bernhard Förster GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K200125 | Thermoforming Sheet MaterialsSummary page 5…nclassified Product Code MQC III) Predicate Device 510(k) Number K200125 Applicant Erkodent Erich Kopp GmbH Trade Name… | 2020 |
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 46 years and passes through 6 companies; a new generation was cleared every 8.2 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. 2024, 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?
Thermoforming Sheet Materials Track A, B, E and Bleach are indicated for the fabrication of orthodontic and dental appliances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241311: Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241311
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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