510(k) · Cleared
ClearedFREEPRINT® splintmaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Detax GmbH · MQC Mouthguard, Prescription
Cleared on Oct 12, 2023 as substantially equivalent to K211415 (Pro3Dure Medical GmbH, 2021) and 2 other predicates after a 59-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Oct 12, 2023
- Review
- 59 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K924830 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 6 generations backK060293 Temporary Crown and Bridge MaterialDentsply International, Inc. · 2006
- 5 generations backK071548 Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007
- 4 generations backK150432 Idodentine Disc, Idodentine BlockUnion Dental S.A. · 2015
- 3 generations backK190107 VeriSplintWhip Mix Corporation · 2019
- 2 generations backK203000 KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 2021 · Recalled
- 1 generation backK211415 GR Splint Resin SystemPro3Dure Medical GmbH · 2021
- This deviceK232448 FREEPRINT® splintmasterDetax GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −6 | K060293 | Temporary Crown and Bridge Material | Dentsply International, Inc. | 2006 | — |
| −5 | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | Merz Dental GmbH | 2007 | — |
| −4 | K150432 | Idodentine Disc, Idodentine Block | Union Dental S.A. | 2015 | — |
| −3 | K190107 | VeriSplint | Whip Mix Corporation | 2019 | — |
| −2 | K203000 | KeyPrint KeySplint Hard | Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | 2021 | 1 |
| −1 | K211415 | GR Splint Resin System | Pro3Dure Medical GmbH | 2021 | — |
| 0 (this device) | K232448 | FREEPRINT® splintmaster | Detax GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K211415 | GR Splint Resin SystemSummary page 5…and design principles to the following Predicate device. 510(k) Primary Predicate Device Name Company Name K211415 GR Splint Resin System Pro3dure Medical GmbH 510(k) Secondary Predic… | 2021 |
| * | K183598 | KeyPrint KeySplint SoftSummary page 5…nt Resin System Pro3dure Medical GmbH 510(k) Secondary Predicate Device Name Company Name K183598 KeyPrint KeySplint Soft Keystone Industries K203000 KeyPrint Ke… | 2019 |
| * | K203000 | KeyPrint KeySplint HardSummary page 5…edicate Device Name Company Name K183598 KeyPrint KeySplint Soft Keystone Industries K203000 KeyPrint KeySplint Hard Keystone Industries INDICATIONS FOR USE FREEPRINT® splintmaster i… | 2021 |
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 29 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K211415.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
FREEPRINT@ splintmaster is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment. FREEPRINT@ splintmaster is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232448: FREEPRINT® splintmaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232448
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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