510(k) · Cleared
ClearedDailyMate Orthodontic Aligner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Global Biotech, Inc. · NXC Aligner, Sequential
Cleared on May 23, 2022 as substantially equivalent to K182329 (Digital Orthodontic Care, 2018) after a 263-day review. Its family tree reaches back 6 generations to 1978. 2 later devices descend from it.
- Decided
- May 23, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K780619 (1978). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 5 generations backK981095 Align SystemAlign Technology · 1998
- 4 generations backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- 3 generations backK082556 ClearcorrectClearcorrect, Inc. · 2009
- 2 generations backK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- 1 generation backK182329 SureCure Orthodontic Aligner SystemDigital Orthodontic Care · 2018
- This deviceK212803 DailyMate Orthodontic Aligner System3D Global Biotech, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK233356 Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK251454 Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited · 2026
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 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −5 | K981095 | Align System | Align Technology | 1998 | — |
| −4 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| −3 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| −2 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| −1 | K182329 | SureCure Orthodontic Aligner System | Digital Orthodontic Care | 2018 | — |
| 0 (this device) | K212803 | DailyMate Orthodontic Aligner System | 3D Global Biotech, Inc. | 2022 | — |
| +1 | K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | 2024 | — |
| +2 | K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 NXC? 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 NXC device
- #1 K220287 Invisalign Systemscore 20.3 · 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 |
|---|---|---|---|
| * | K182329 | SureCure Orthodontic Aligner SystemSummary page 4…21 CFR 872.5470 DEVICE CLASSIFICATION: CLASS II CLASSIFICATION PRODUCT CODE: NXC Predicate Device Primary SureCure Orthodontic K182329 Digital Orthodontic Predicate Aligner System Care Reference… | 2018 |
| † | K143630 | Invisalign System | 2015 |
| † | K152086 | 3Shape Ortho System | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233356 | Illusion Aligner Pro: Illusion Aligner FLX | 2024 | 1 |
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 44 years and passes through 6 companies; a new generation was cleared every 6.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K233356 (Laxmi Dental Export Pvt., Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NXC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NXC
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXC
4,523in 2025
MAUDE reports naming product code NXC, 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 | 1 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 59 |
| 2012 | 2 | — | 0 | 24 |
| 2013 | 4 | 124 | 0 | 28 |
| 2014 | 0 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 43 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 3 | 85 | 0 | 47 |
| 2018 | 11 | 116 | 0 | 67 |
| 2019 | 16 | 182 | 0 | 127 |
| 2020 | 16 | 230 | 0 | 175 |
| 2021 | 20 | 97 | 0 | 929 |
| 2022 | 19 | 137 | 0 | 605 |
| 2023 | 13 | 152 | 0 | 433 |
| 2024 | 14 | 105 | 2 | 8,991 |
| 2025 | 11 | 61 | 0 | 4,523 |
| 2026 | 5 | 127 | 0 | — |
What is it indicated for?
The DailyMate Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212803 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212803: DailyMate Orthodontic Aligner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212803
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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