510(k) · Cleared
Recalled · Class II · 2023KeyPrint KeySplint Hard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mycone Dental Supply Co. Inc. (Dba Keystone Industries) · MQC Mouthguard, Prescription
Cleared on Apr 9, 2021 as substantially equivalent to K183598 (Keystone Industries, 2019) and 1 other predicate after a 190-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Apr 9, 2021
- Review
- 190 days
- Class
- Class U
- Product code
- MQC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924830 (1994). 7 ancestors in all. 6 later devices descend from it, 5 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 backK190107 VeriSplintWhip Mix Corporation · 2019
- This deviceK203000 KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 2021
- Descendant · cites it directly · 2 of its ownK211415 GR Splint Resin SystemPro3Dure Medical GmbH · 2021
- Descendant · cites it directly · 1 of its ownK222061 Dental LT Clear V2 ResinFormlabs Ohio, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK253798 UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc. · 2026
- Descendant · cites it directly · 0 of its ownK231775 GR Resin System MSIPro3Dure Medical · 2024
- Descendant · 2 generations on · 0 of its ownK232087 Dental LT Comfort ResinFormlabs Ohio, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211415GR Splint Resin SystemPro3Dure Medical GmbH · 2021 · cites it directly2descendants
- K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc. · 2022 · cites it directly1descendant
- K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc. · 2026 · cites it directly0descendants
- K231775GR Resin System MSIPro3Dure Medical · 2024 · cites it directly0descendants
- K232087Dental LT Comfort ResinFormlabs Ohio, Inc. · 2024 · 2 generations on0descendants
View 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 | K190107 | VeriSplint | Whip Mix Corporation | 2019 | — |
| 0 (this device) | K203000 | KeyPrint KeySplint Hard | Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | 2021 | — |
| +1 | K211415 | GR Splint Resin System | Pro3Dure Medical GmbH | 2021 | — |
| +1 | K222061 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | 2022 | — |
| +1 | K253798 | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | 2026 | — |
| +1 | K231775 | GR Resin System MSI | Pro3Dure Medical | 2024 | — |
| +2 | K232087 | Dental LT Comfort Resin | Formlabs Ohio, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 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 K260031 Thermeo® I Msiscore 13.9 · 7 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.
What descends from it? (6)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2023 | Class II | Z-0630-2024 | Labeling mix-ups | Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K211415 (Pro3Dure Medical GmbH, 2021) has gone furthest, with 2 descendants of its own.
- 10 other devices also cite its predicate K183598.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 KeyPrint" KeySplint HardTM device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners and retainers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203000: KeyPrint KeySplint Hard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203000
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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