510(k) Report

510(k) · Cleared

Cleared

Invisalign System with Mandibular Advancement Feature

K181739510(k) TraditionalCleared Oct 26, 2018116-day reviewClass II21 CFR 872.5470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Align Technology, Inc. · NXC Aligner, Sequential

Cleared on Oct 26, 2018 as substantially equivalent to K143630 (Align Technology, Inc., 2015) after a 116-day review. Its family tree reaches back 4 generations to 1978. 18 later devices descend from it.

Decided
Oct 26, 2018
Review
116 days
Class
Class II
Product code
NXC
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K780619 (1978). 18 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2023: 3 descendants cleared2022: 3 descendants cleared2026: 3 descendants cleared2024: 3 descendants cleared2025: 5 descendants clearedK780619 · Preformed Tooth Positioner · Tp Laboratories, Inc. · 1978K981095 · Align System · Align Technology · 1998K081960 · Invisalign System · Align Technology · 2008K143630 · Invisalign System · Align Technology, Inc. · 201519801990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 8 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K143630 · Invisalign System · Align Technology, Inc. · 2015K081960 · Invisalign System · Align Technology · 2008K981095 · Align System · Align Technology · 1998K780619 · Preformed Tooth Positioner · Tp Laboratories, Inc. · 19780+5
  1. Root · 4 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
  2. 3 generations backK981095 Align SystemAlign Technology · 1998
  3. 2 generations backK081960 Invisalign SystemAlign Technology · 2008
  4. 1 generation backK143630 Invisalign SystemAlign Technology, Inc. · 2015
  5. This deviceK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
  6. Descendant · cites it directly · 13 of its ownK220287 Invisalign SystemAlign Technology, Inc. · 2022 · Recalled
  7. Descendant · 2 generations on · 3 of its ownK232233 Invisalign System with Mandibular Advancement Featuring Occlusal…Align Technology, Inc. · 2023
  8. Descendant · 3 generations on · 2 of its ownK241412 Invisalign SystemAlign Technology, Inc. · 2024
  9. Descendant · 2 generations on · 2 of its ownK222418 NuvolaGruppo Europeo Ortodonzia Srl · 2022
  10. Descendant · 4 generations on · 1 of its ownK252380 Invisalign SystemAlign Technology, Inc. · 2025

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2020: 12022: 32023: 32024: 32025: 52026: 3
2020high 5 (2025) · low 0 (2021)2026

Most influential descendants

Showing 5 of 18 · See all
  • K220287Invisalign SystemAlign Technology, Inc. · 2022 · cites it directly13descendants
  • K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc. · 2023 · 2 generations on3descendants
  • K241412Invisalign SystemAlign Technology, Inc. · 2024 · 3 generations on2descendants
  • K222418NuvolaGruppo Europeo Ortodonzia Srl · 2022 · 2 generations on2descendants
  • K252380Invisalign SystemAlign Technology, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K780619Preformed Tooth PositionerTp Laboratories, Inc.1978—
−3K981095Align SystemAlign Technology1998—
−2K081960Invisalign SystemAlign Technology2008—
−1K143630Invisalign SystemAlign Technology, Inc.2015—
0 (this device)K181739Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc.2018—
+1K220287Invisalign SystemAlign Technology, Inc.20221
+2K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksAlign Technology, Inc.2023—
+3K241412Invisalign SystemAlign Technology, Inc.2024—
+2K222418NuvolaGruppo Europeo Ortodonzia Srl2022—
+4K252380Invisalign SystemAlign Technology, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202230
202330
202430
202550
202630
FIG. 1 — Lineage of K181739, 1978–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220287 Invisalign Systemscore 20.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K143630Invisalign System
Summary page 4
…redicate Device: Proprietary Name Invisalign Orthodontic System Common Name Aligner, Sequential Premarket Notification K143630 Classification Name Orthodontic Plastic Bracket Regulation Number 21 CFR 872.5470 Product C…
Align Technology, Inc.2015—

Also cleared against K143630: 4 other devices →

What descends from it? (18)

See all 18

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K220287Invisalign SystemAlign Technology, Inc.202213
K223517Clear AlignerWuxi EA Medical Instruments Technologies Limited.20231
K192069Aerodentis SystemDror Orthodesign20201

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 40 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K220287 (Align Technology, Inc., 2022) has gone furthest, with 13 descendants of its own.
  • 4 other devices also cite its predicate K143630.

How does its category compare?

All NXC devices

NXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · NXC

11in 2025

2007: 12008: 22009: 22010: 12012: 22013: 42015: 22016: 12017: 32018: 112019: 162020: 162021: 202022: 192023: 132024: 142025: 112026 (partial year): 5
2007high 20 (2021) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NXC

61in 2025

2013: 124 days median2017: 85 days median2018: 116 days median2019: 182 days median2020: 230 days median2021: 97 days median2022: 137 days median2023: 152 days median2024: 105 days median2025: 61 days median2026 (partial year): 127 days median
2007high 230 (2020) · low 61 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NXC

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NXC

4,523in 2025

2007: 12008: 52009: 22010: 112011: 592012: 242013: 282014: 272015: 432016: 412017: 472018: 672019: 1272020: 1752021: 9292022: 6052023: 4332024: 8,9912025: 4,523
2007high 8,991 (2024) · low 1 (2007)2025

MAUDE reports naming product code NXC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20082—05
20092—02
20101—011
20110—059
20122—024
20134124028
20140—027
20152—043
20161—041
2017385047
201811116067
2019161820127
2020162300175
202120970929
2022191370605
2023131520433
20241410528,991
2025116104,523
202651270—

What is it indicated for?

The Invisalign System is indicated for the orthodontic treatment of malocclusion.

Indications for use as stated in the FDA summary.

Also cleared against K143630

4 other devices cite the same predicate.

  • K220140ClearCorrect SystemClearcorrect, LLC · 2022
  • K203737Spark Clear Aligner SystemOrmco Corporation · 2021
  • K182826Ormco Spark Aligner SystemSybron Dental Specialties · 2018
  • K171674Angel Align SystemSmile Development Corp · 2018

More from Align Technology, Inc.

12 FDA decisions under this applicant name. See the company

  • K262196Invisalign SystemAlign Technology, Inc. · 2026
  • K252931Invisalign® Palatal Expander SystemAlign Technology, Inc. · 2025
  • K252870Invisalign Specifix Attachment SystemAlign Technology, Inc. · 2025
  • K252380Invisalign SystemAlign Technology, Inc. · 2025
  • K241412Invisalign SystemAlign Technology, Inc. · 2024

Recent decisions in NXC

The NXC category page

  • K260527FACE4D AlignerAvinent Implant System S.L.U. · 2026
  • K260788Smylio AlignersSmylio, Inc. · 2026
  • K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc. · 2026
  • K253282ZSmile SystemDror Orthodesign, Ltd. · 2026
  • K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited · 2026

https://510kreport.com/device/K181739 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181739: Invisalign System with Mandibular Advancement Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181739

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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