510(k) · Cleared
ClearedCarriere® Motion Pro® Clear Bite Corrector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Organizers, Inc. · DYW Bracket, Plastic, Orthodontic
Cleared on Nov 27, 2025 as substantially equivalent to K160720 (Ortho Organizers, Inc., 2016) after a 90-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Nov 27, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K160720 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK160720 Carriere Motion Clear Class IIOrtho Organizers, Inc. · 2016
- This deviceK252760 Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K160720 | Carriere Motion Clear Class II | Ortho Organizers, Inc. | 2016 | — |
| 0 (this device) | K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | 2025 | — |
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 DYW? 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 DYW device
- #1 K251196 Composite Orthodontic Brackets and Buttonsscore 9.2 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K160720 | Carriere Motion Clear Class IISummary page 5…Class I, 510(k) Exempt (Primary Predicate) Product Code: EJF (Bracket, Metal, Orthodontic) Device Trade Name: Carriere Motion Clear Class II 510(k) Number: K160720 (Secondary Predicate) Product Code: DYW (primary), EJF Ortho Organizers, Inc. • Traditional 510(k) Submission • Carriere… | 2016 |
| * | — | Carriere® Motion Pro® Bite Corrector Named without a submission number |
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?
- Its one ancestor has no recall.
How does its category compare?
All DYW devicesDYW Bracket, Plastic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DYW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYW
372in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYW
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYW
1in 2017
MAUDE reports naming product code DYW, 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 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 3 | 372 | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Carriere® Motion Pro® Clear Bite Corrector is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II and Class III cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars or mandibular crowding. The appliance is indicated for use by dental and orthodontic professionals and is applicable to any patient demographic undergoing orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252760 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252760: Carriere® Motion Pro® Clear Bite Corrector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252760
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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