510(k) · Cleared
ClearedClear Image Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Appliance Works, Inc. · NXC Aligner, Sequential
Cleared on Sep 25, 2007 as substantially equivalent to K981095 (Align Technology, 1998) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1978. 67 later devices descend from it.
- Decided
- Sep 25, 2007
- Review
- 70 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K780619 (1978). 3 ancestors in all. 67 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 1 generation backK981095 Align SystemAlign Technology · 1998
- This deviceK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- Descendant · cites it directly · 64 of its ownK082556 ClearcorrectClearcorrect, Inc. · 2009
- Descendant · 2 generations on · 60 of its ownK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- Descendant · 3 generations on · 15 of its ownK180241 Orthocaps TwinalignerOrtho Caps GmbH · 2018
- Descendant · 3 generations on · 13 of its ownK163689 3M Clear Tray Aligner3M Unitek Corporation · 2017
- Descendant · 4 generations on · 8 of its ownK192596 ULab Systems Dental Aligner KitUlab Systems, Inc. · 2020
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K082556ClearcorrectClearcorrect, Inc. · 2009 · cites it directly64descendants
- K113618Clearcorrect SystemClearcorrect, Inc. · 2012 · 2 generations on60descendants
- K180241Orthocaps TwinalignerOrtho Caps GmbH · 2018 · 3 generations on15descendants
- K1636893M Clear Tray Aligner3M Unitek Corporation · 2017 · 3 generations on13descendants
- K192596ULab Systems Dental Aligner KitUlab Systems, Inc. · 2020 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −1 | K981095 | Align System | Align Technology | 1998 | — |
| 0 (this device) | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| +1 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| +2 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| +3 | K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | 2018 | — |
| +3 | K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | 2017 | — |
| +4 | K192596 | ULab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 7 | 0 |
| 2019 | 12 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 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? (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 |
|---|---|---|---|
| * | K981095 | Align SystemSummary page 2…ther FDA approved legally marketed orthodontic devices in the United States. ClearImageTMAligners is used in a manner similar to the Invisalign system, K981095, marketed by Align Technology and Red, White & Blue, K040879, marketed by Allesee Orthodontic Appliances.… | 1998 |
| * | K040874 | Red, White & Blue Our reading of the summary gave K040879, FDA’s number for Quantex Ferritin (Instrumentation Laboratory CO). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Red, White & Blue”. | 2004 |
What descends from it? (67)
See all 675 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 29 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082556 (Clearcorrect, Inc., 2009) has gone furthest, with 64 descendants of its own.
- 8 other devices also cite its predicate K981095.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Clear ImageTM Aligners system is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align the teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071970: Clear Image Aligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071970
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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