510(k) · Cleared
ClearedThermoforming Sheet Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erkodent Erich Kopp GmbH · MQC Mouthguard, Prescription
Cleared on Oct 28, 2020 as substantially equivalent to K072522 (Dentsply International, Inc., 2007) and 1 other predicate after a 281-day review. Its family tree reaches back 4 generations to 1978. 1 later device descends from it.
- Decided
- Oct 28, 2020
- Review
- 281 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K780619 (1978). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 3 generations backK981095 Align SystemAlign Technology · 1998
- 2 generations backK062828 Mouthguard and Aligner MaterialsDentsply Intl., Inc. · 2006
- 1 generation backK072522 Thermoform Sheet Materials and AccessoriesDentsply International, Inc. · 2007
- This deviceK200125 Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH · 2020
- Descendant · cites it directly · 0 of its ownK241311 Thermoforming Sheet Materials (Track A); Thermoforming Sheet…Bernhard Förster GmbH · 2024
Most influential descendants
Showing 1 of 1 · See all- K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B)…Bernhard Förster GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −3 | K981095 | Align System | Align Technology | 1998 | — |
| −2 | K062828 | Mouthguard and Aligner Materials | Dentsply Intl., Inc. | 2006 | — |
| −1 | K072522 | Thermoform Sheet Materials and Accessories | Dentsply International, Inc. | 2007 | — |
| 0 (this device) | K200125 | Thermoforming Sheet Materials | Erkodent Erich Kopp GmbH | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 15.4 · 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? (2)
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 |
|---|---|---|---|
| * | K072522 | Thermoform Sheet Materials and AccessoriesSummary page 5…Predicate Devices: Primary predicate: Thermoform Sheet Materials and Accessories, K072522 Reference device: Mouthguard and Aligner Materials K062… | 2007 |
| * | K062828 | Mouthguard and Aligner MaterialsSummary page 5…K072522 Reference device: Mouthguard and Aligner Materials K062828 E. Device Description: Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plasti… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B)… | 2024 | 0 |
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 42 years and passes through 5 companies; a new generation was cleared every 13.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K241311 (Bernhard Förster GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072522.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 are indicated for the fabrication of orthodontic and dental appliances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200125: Thermoforming Sheet Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200125
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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