510(k) · Cleared
ClearedCarriere Motion Clear Class II
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 28, 2016 after a 257-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 28, 2016
- Review
- 257 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK160720 Carriere Motion Clear Class IIOrtho Organizers, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK252760 Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K160720 | Carriere Motion Clear Class II | Ortho Organizers, Inc. | 2016 | — |
| +1 | K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 K252760 Carriere® Motion Pro® Clear Bite Correctorscore 10.4 · 1 generation · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Carriere Motion Class II Named without a submission number | |
| † | K140807 | Composite Orthodontic Brackets | 2014 |
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 |
|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | 2025 | 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?
- Of its descendants, K252760 (Ortho Organizers, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DYW devicesDYW Bracket, Plastic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars.
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/K160720 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160720: Carriere Motion Clear Class II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160720
Report an extraction error
Are you the manufacturer?
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