510(k) · Cleared
ClearedGR Splint Resin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro3Dure Medical GmbH · MQC Mouthguard, Prescription
Cleared on Oct 21, 2021 as substantially equivalent to K203000 (Mycone Dental Supply Co. Inc. (Dba Keystone Industries), 2021) and 1 other predicate after a 168-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 21, 2021
- Review
- 168 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924830 (1994). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 5 generations backK060293 Temporary Crown and Bridge MaterialDentsply International, Inc. · 2006
- 4 generations backK071548 Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007
- 3 generations backK150432 Idodentine Disc, Idodentine BlockUnion Dental S.A. · 2015
- 2 generations backK190107 VeriSplintWhip Mix Corporation · 2019
- 1 generation backK203000 KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 2021 · Recalled
- This deviceK211415 GR Splint Resin SystemPro3Dure Medical GmbH · 2021
- Descendant · cites it directly · 0 of its ownK231775 GR Resin System MSIPro3Dure Medical · 2024
- Descendant · cites it directly · 0 of its ownK232448 FREEPRINT® splintmasterDetax GmbH · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −5 | K060293 | Temporary Crown and Bridge Material | Dentsply International, Inc. | 2006 | — |
| −4 | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | Merz Dental GmbH | 2007 | — |
| −3 | K150432 | Idodentine Disc, Idodentine Block | Union Dental S.A. | 2015 | — |
| −2 | K190107 | VeriSplint | Whip Mix Corporation | 2019 | — |
| −1 | K203000 | KeyPrint KeySplint Hard | Mycone Dental Supply Co. Inc. (Dba Keystone Industries) | 2021 | 1 |
| 0 (this device) | K211415 | GR Splint Resin System | Pro3Dure Medical GmbH | 2021 | — |
| +1 | K231775 | GR Resin System MSI | Pro3Dure Medical | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 15.3 · 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? (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 |
|---|---|---|---|
| * | K203000 | KeyPrint KeySplint HardSummary page 4…l 30, 2021 Classification: Unclassified Product Codes: MQC Additional Product Codes: EBI, KMY Primary Predicate Device: KeyPrint KeySplint Hard (K203000) Additional Predicate: KeyPrint KeySplint Soft (K183598) Reference Device: Pro3dure GR-17 Resin System (K201827) I… | 2021 |
| * | K183598 | KeyPrint KeySplint SoftSummary page 4…odes: MQC Additional Product Codes: EBI, KMY Primary Predicate Device: KeyPrint KeySplint Hard (K203000) Additional Predicate: KeyPrint KeySplint Soft (K183598) Reference Device: Pro3dure GR-17 Resin System (K201827) Indications for Use: The GR Splint Resin System is a ligh… | 2019 |
| † | K201827 | GR-17 Resin System | 2020 |
What descends from it? (2)
2 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 27 years and passes through 7 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K231775 (Pro3Dure Medical, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K203000.
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 GR Splint Resin System is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment:
The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.
The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
The GR-22 flex 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/K211415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211415: GR Splint Resin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211415
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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