510(k) · Cleared
ClearedKrystal Klear Aligners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shatkin F.I.R.S.T., LLC · NXC Aligner, Sequential
Cleared on Dec 19, 2019 as substantially equivalent to K071970 (Specialty Appliance Works, Inc., 2007) after a 471-day review. Its family tree reaches back 3 generations to 1978.
- Decided
- Dec 19, 2019
- Review
- 471 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K780619 (1978). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 2 generations backK981095 Align SystemAlign Technology · 1998
- 1 generation backK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- This deviceK182388 Krystal Klear AlignersShatkin F.I.R.S.T., LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −2 | K981095 | Align System | Align Technology | 1998 | — |
| −1 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| 0 (this device) | K182388 | Krystal Klear Aligners | Shatkin F.I.R.S.T., LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K071970 | Clear Image AlignerSummary page 4…ication Panel: Dental Products Panel 76 Classification: Medical Device, Class II Predicate Devices: Clear Image Aligners, Specialty Appliance Works, K071970 (Primary Predicate) Clear Correct, Clear Correct Inc., K082556 (Reference Device) Invisalign, Align Technology, K981095 (Referenc… | 2007 |
| † | K082556 | Clearcorrect | 2009 |
| † | K981095 | Align System | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 41 years and passes through 4 companies; a new generation was cleared every 12.2 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K071970.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Krystal Klear 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182388: Krystal Klear Aligners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182388
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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