510(k) · Cleared
ClearedMouthguard and Aligner Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl., Inc. · MQC Mouthguard, Prescription
Cleared on Nov 27, 2006 as substantially equivalent to K053580 (Dental Concepts, LLC, 2006) and 2 other predicates after a 68-day review. Its family tree reaches back 2 generations to 1978. 6 later devices descend from it.
- Decided
- Nov 27, 2006
- Review
- 68 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K780619 (1978). 6 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 1 generation backK981095 Align SystemAlign Technology · 1998
- This deviceK062828 Mouthguard and Aligner MaterialsDentsply Intl., Inc. · 2006
- Descendant · cites it directly · 3 of its ownK072522 Thermoform Sheet Materials and AccessoriesDentsply International, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK200125 Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH · 2020
- Descendant · cites it directly · 1 of its ownK134015 M-PM-DiscMerz Dental GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK241311 Thermoforming Sheet Materials (Track A); Thermoforming Sheet…Bernhard Förster GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK191836 Ceramill A-SplintAmann Girrbach AG · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K072522Thermoform Sheet Materials and AccessoriesDentsply International, Inc. · 2007 · cites it directly3descendants
- K200125Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH · 2020 · cites it directly1descendant
- K134015M-PM-DiscMerz Dental GmbH · 2014 · cites it directly1descendant
- K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B)…Bernhard Förster GmbH · 2024 · 2 generations on0descendants
- K191836Ceramill A-SplintAmann Girrbach AG · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −1 | K981095 | Align System | Align Technology | 1998 | — |
| 0 (this device) | K062828 | Mouthguard and Aligner Materials | Dentsply Intl., Inc. | 2006 | — |
| +1 | K072522 | Thermoform Sheet Materials and Accessories | Dentsply International, Inc. | 2007 | — |
| +1 | K200125 | Thermoforming Sheet Materials | Erkodent Erich Kopp GmbH | 2020 | — |
| +1 | K134015 | M-PM-Disc | Merz Dental GmbH | 2014 | — |
| +2 | K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track… | Bernhard Förster GmbH | 2024 | — |
| +2 | K191836 | Ceramill A-Splint | Amann Girrbach AG | 2019 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K053580 | Doctor's NightguardSummary page 1…nclassified Orthodontic plastic bracket, 872.5470 PREDICATE DEVICES: The Doctor's® NightGuardI m, K053580 EZ Splint!/ EZ Splint PM, K022809 Align… | 2006 |
| * | K022809 | EZ Splint & EZ Splint PMSummary page 1…acket, 872.5470 PREDICATE DEVICES: The Doctor's® NightGuardI m, K053580 EZ Splint!/ EZ Splint PM, K022809 Align System, K98 1095 DEVICE DESCRIPTION: MOUTHGUARD AND ALIGNER MATERIALS are p… | 2003 |
| * | K981095 | Align SystemSummary page 1…octor's® NightGuardI m, K053580 EZ Splint!/ EZ Splint PM, K022809 Align System, K98 1095 DEVICE DESCRIPTION: MOUTHGUARD AND ALIGNER MATERIALS are plastic, resin, or laminate materials that are sold for the purpose o… | 1998 |
What descends from it? (6)
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K072522 (Dentsply International, Inc., 2007) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K053580.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062828: Mouthguard and Aligner Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062828
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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