510(k) · Cleared
ClearedNextDent Ortho Flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertex-Dental B.V. · MQC Mouthguard, Prescription
Cleared on Oct 21, 2022 as substantially equivalent to K212448 (Sprintray, Inc., 2021) after a 198-day review. Its family tree reaches back 2 generations to 2019. 1 later device descends from it.
- Decided
- Oct 21, 2022
- Review
- 198 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183598 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK183598 KeyPrint KeySplint SoftKeystone Industries · 2019 · Recalled
- 1 generation backK212448 NightGuard FlexSprintray, Inc. · 2021
- This deviceK221022 NextDent Ortho FlexVertex-Dental B.V. · 2022
- Descendant · cites it directly · 0 of its ownK251415 Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183598 | KeyPrint KeySplint Soft | Keystone Industries | 2019 | 1 |
| −1 | K212448 | NightGuard Flex | Sprintray, Inc. | 2021 | — |
| 0 (this device) | K221022 | NextDent Ortho Flex | Vertex-Dental B.V. | 2022 | — |
| +1 | K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K212448 | NightGuard FlexSummary page 4…N.a. 21 CFR 872.5525 Regulation III. PREDICATE Nightguard Flex, K212448 (Primary predicate) DEVICE(s) IV. DEVICE DESCRIPTION Device Identification: Light-Cure Resin, provided in a container. Devic… | 2021 |
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 |
|---|---|---|---|
| K251415 | Additively Manufactured Aligner Resin | 2025 | 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 3 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K251415 (Aidite (Qinhuangdao) Technology Co., Ltd., 2025) has gone furthest, with 0 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. 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?
NextDent Ortho Flex is a 3D print resin intended for the manufacturing of 3D printed dental splints and retainers. To retain the regulated dentition.
NextDent Ortho Flex is intended exclusively for professional dental work.
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/K221022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221022: NextDent Ortho Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221022
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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