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 Jul 8, 2016 as substantially equivalent to K130643 (Orthoaccel Technologies, Inc., 2013) and 1 other predicate after a 263-day review. Its family tree reaches back 4 generations to 1993. 2 later devices descend from it.
- Decided
- Jul 8, 2016
- Review
- 263 days
- Class
- Class II
- Product code
- OYH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K924975 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK924975 The OrthotrainerMyofunctional Research Corp. Pty., Ltd. · 1993
- 3 generations backK110661 AcceledentOrthoaccel Technologies, Inc. · 2011
- 2 generations backK130643 Acceledent AuraOrthoaccel Technologies, Inc. · 2013
- 1 generation backK143120 OrthoPulseBiolux Research, Ltd. · 2015
- This deviceK153048 AcceleDent AuraOrthoaccel Technologies, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK183018 VPro5Propel Orthodontics, LLC · 2019
- Descendant · cites it directly · 0 of its ownK170093 AcceleDent OptimaOrthoaccel Technology, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924975 | The Orthotrainer | Myofunctional Research Corp. Pty., Ltd. | 1993 | — |
| −3 | K110661 | Acceledent | Orthoaccel Technologies, Inc. | 2011 | — |
| −2 | K130643 | Acceledent Aura | Orthoaccel Technologies, Inc. | 2013 | — |
| −1 | K143120 | OrthoPulse | Biolux Research, Ltd. | 2015 | — |
| 0 (this device) | K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. | 2016 | — |
| +1 | K183018 | VPro5 | Propel Orthodontics, LLC | 2019 | — |
| +1 | K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K130643 | Acceledent AuraSummary page 4…Dental Product codes: OYH Product code names Orthodontic vibratory accessory Predicate Device: AcceleDent® Aura, 510(k) Number K130643 Secondary Predicate Device: OrthoPulse™, 510(k) Number K143120 Indications for Use: AcceleDent® Aura is intended for use during… | 2013 |
| * | K143120 | OrthoPulseSummary page 4…names Orthodontic vibratory accessory Predicate Device: AcceleDent® Aura, 510(k) Number K130643 Secondary Predicate Device: OrthoPulse™, 510(k) Number K143120 Indications for Use: AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets… | 2015 |
What descends from it? (2)
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 23 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K183018 (Propel Orthodontics, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130643.
How does its category compare?
All OYH devicesOYH Orthodontic Vibratory Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153048: 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/K153048
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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