510(k) · Cleared
ClearedAcceledent Aura
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthoaccel Technologies, Inc. · OYH Orthodontic Vibratory Accessory
Cleared on Apr 23, 2013 as substantially equivalent to K110661 (Orthoaccel Technologies, Inc., 2011) after a 43-day review. Its family tree reaches back 2 generations to 1993. 5 later devices descend from it.
- Decided
- Apr 23, 2013
- Review
- 43 days
- Class
- Class II
- Product code
- OYH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924975 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK924975 The OrthotrainerMyofunctional Research Corp. Pty., Ltd. · 1993
- 1 generation backK110661 AcceledentOrthoaccel Technologies, Inc. · 2011
- This deviceK130643 Acceledent AuraOrthoaccel Technologies, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK143120 OrthoPulseBiolux Research, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK153048 AcceleDent AuraOrthoaccel Technologies, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK230905 OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK183018 VPro5Propel Orthodontics, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK170093 AcceleDent OptimaOrthoaccel Technology, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K143120OrthoPulseBiolux Research, Ltd. · 2015 · cites it directly4descendants
- K153048AcceleDent AuraOrthoaccel Technologies, Inc. · 2016 · cites it directly2descendants
- K230905OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH · 2023 · 2 generations on0descendants
- K183018VPro5Propel Orthodontics, LLC · 2019 · 2 generations on0descendants
- K170093AcceleDent OptimaOrthoaccel Technology, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924975 | The Orthotrainer | Myofunctional Research Corp. Pty., Ltd. | 1993 | — |
| −1 | K110661 | Acceledent | Orthoaccel Technologies, Inc. | 2011 | — |
| 0 (this device) | K130643 | Acceledent Aura | Orthoaccel Technologies, Inc. | 2013 | — |
| +1 | K143120 | OrthoPulse | Biolux Research, Ltd. | 2015 | — |
| +1 | K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. | 2016 | — |
| +2 | K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | 2023 | — |
| +2 | K183018 | VPro5 | Propel Orthodontics, LLC | 2019 | — |
| +2 | K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 OYH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K110661 | AcceledentSummary page 1…0 Classification: Class 11 Panel: Dental Product code: OYIH Predicate Device: AcceleDent®, 510(k) Number K110661 Device Description: AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. It is used as an adjun… | 2011 |
What descends from it? (5)
2 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 20 years and passes through 2 companies; a new generation was cleared every 18.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143120 (Biolux Research, Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K110661.
How does its category compare?
All OYH devicesOYH Orthodontic Vibratory Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OYH
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · OYH
Too few OYH 510(k)s in any year since 2007 to give a median.
Recalls per year · OYH
No recall names OYH since 2007.
Adverse event reports per year · OYH
2in 2025
MAUDE reports naming product code OYH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AcceleDent® Aura is intended for use during orthodontic treatment. it is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130643: Acceledent Aura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130643
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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