510(k) · Cleared
ClearedDental LT Clear V2 Resin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Formlabs Ohio, Inc. · MQC Mouthguard, Prescription
Cleared on Nov 10, 2022 as substantially equivalent to K203000 (Mycone Dental Supply Co. Inc. (Dba Keystone Industries), 2021) and 1 other predicate after a 120-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.
- Decided
- Nov 10, 2022
- Review
- 120 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. 1 later device descends from it, 1 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 deviceK222061 Dental LT Clear V2 ResinFormlabs Ohio, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK232087 Dental LT Comfort ResinFormlabs Ohio, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232087Dental LT Comfort ResinFormlabs Ohio, Inc. · 2024 · cites it directly0descendants
View 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) | K222061 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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…(Positioner, Tooth, Preformed), DYT (Maintainer, Space Preformed, Orthodontic) Panel: Dental 9. Predicate Devices: Primary Predicate Device: KeyPrint® KeySplint Hard™ (K203000) Secondary Predicate Device: KeyPrint® KeySplint Soft™ (K183598)… | 2021 |
| * | K183598 | KeyPrint KeySplint SoftSummary page 4…, Orthodontic) Panel: Dental 9. Predicate Devices: Primary Predicate Device: KeyPrint® KeySplint Hard™ (K203000) Secondary Predicate Device: KeyPrint® KeySplint Soft™ (K183598) 1… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232087 | Dental LT Comfort Resin | 2024 | 0 |
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 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, K232087 (Formlabs Ohio, Inc., 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. 2022, 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?
Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222061: Dental LT Clear V2 Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222061
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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