510(k) · Cleared
ClearedOhlendorf Clear Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohlendorf Appliance Laboratory · NXC Aligner, Sequential
Cleared on May 19, 2021 as substantially equivalent to K182826 (Sybron Dental Specialties, 2018) after an 84-day review. Its family tree reaches back 5 generations to 1978. 1 later device descends from it.
- Decided
- May 19, 2021
- Review
- 84 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K780619 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 4 generations backK981095 Align SystemAlign Technology · 1998
- 3 generations backK081960 Invisalign SystemAlign Technology · 2008
- 2 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 1 generation backK182826 Ormco Spark Aligner SystemSybron Dental Specialties · 2018
- This deviceK210540 Ohlendorf Clear AlignerOhlendorf Appliance Laboratory · 2021
- Descendant · cites it directly · 0 of its ownK241137 Clear Moves AlignerClear Moves Aligners · 2024
Most influential descendants
Showing 1 of 1 · See all- K241137Clear Moves AlignerClear Moves Aligners · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −4 | K981095 | Align System | Align Technology | 1998 | — |
| −3 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −2 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −1 | K182826 | Ormco Spark Aligner System | Sybron Dental Specialties | 2018 | — |
| 0 (this device) | K210540 | Ohlendorf Clear Aligner | Ohlendorf Appliance Laboratory | 2021 | — |
| +1 | K241137 | Clear Moves Aligner | Clear Moves Aligners | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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 |
|---|---|---|---|
| K241137 | Clear Moves Aligner | 2024 | 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 43 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K241137 (Clear Moves Aligners, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K182826.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Ohlendorf Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The Ohlendorf Clear Alginer positions teeth by way of continuous gentle force.
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/K210540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210540: Ohlendorf Clear Aligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210540
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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