510(k) · Cleared
Recalled · Class II · 2021KeyPrint KeySplint Soft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keystone Industries · MQC Mouthguard, Prescription
Cleared on Nov 15, 2019 after a 324-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it. It has been recalled once.
- Decided
- Nov 15, 2019
- Review
- 324 days
- Class
- Class U
- Product code
- MQC
- Recalls
- 1
- Predicates
- 0
14 later devices descend from it, 11 citing it directly.
- This deviceK183598 KeyPrint KeySplint SoftKeystone Industries · 2019
- Descendant · cites it directly · 6 of its ownK203000 KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK212448 NightGuard FlexSprintray, Inc. · 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 · 2 generations on · 1 of its ownK221022 NextDent Ortho FlexVertex-Dental B.V. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K203000KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 2021 · cites it directly6descendants
- K212448NightGuard FlexSprintray, Inc. · 2021 · cites it directly2descendants
- K211415GR Splint Resin SystemPro3Dure Medical GmbH · 2021 · cites it directly2descendants
- K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc. · 2022 · cites it directly1descendant
- K221022NextDent Ortho FlexVertex-Dental B.V. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183598 | KeyPrint KeySplint Soft | Keystone Industries | 2019 | — |
| +1 | K203000 | KeyPrint KeySplint Hard | Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | 2021 | 1 |
| +1 | K212448 | NightGuard Flex | Sprintray, Inc. | 2021 | — |
| +1 | K211415 | GR Splint Resin System | Pro3Dure Medical GmbH | 2021 | — |
| +1 | K222061 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | 2022 | — |
| +2 | K221022 | NextDent Ortho Flex | Vertex-Dental B.V. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (14)
See all 1411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203000 | KeyPrint KeySplint Hard | 2021 | 6 |
| K212448 | NightGuard Flex | 2021 | 2 |
| K211415 | GR Splint Resin System | 2021 | 2 |
| K222061 | Dental LT Clear V2 Resin | 2022 | 1 |
| K241729 | Hard Splint & Thermo-Adaptive Splint | 2025 | 0 |
| K231775 | GR Resin System MSI | 2024 | 0 |
| K232087 | Dental LT Comfort Resin | 2024 | 0 |
| K232448 | FREEPRINT® splintmaster | 2023 | 0 |
| K223798 | Glidewell TuffSplint™ Appliance Resin | 2023 | 0 |
| K220894 | SmileGuard | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2021 | Class II | Z-2336-2021 | Process control | Product label intended for the European community was distributed to the USA market via their US distribution organization |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K203000 (Mycone Dental Supply Co. Inc. (Dba Keystone Industries), 2021) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K183598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183598: KeyPrint KeySplint Soft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183598
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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