510(k) · Cleared
ClearedReflections
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cdb Corp. · DYW Bracket, Plastic, Orthodontic
Cleared on Nov 21, 1997 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Nov 21, 1997
- Review
- 49 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK973776 ReflectionsCdb Corp. · 1997
- Descendant · cites it directly · 2 of its ownK140807 Composite Orthodontic BracketsOrtho Specialties · 2014
- Descendant · cites it directly · 1 of its ownK113334 Avex CX2 and Avex CXI2 Ceramic BracketsOpal Orthodontics by Ultradent Products, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK251196 Composite Orthodontic Brackets and ButtonsEc Certification Service GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK201940 Braces on Demand BracketBraces on Demand, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK150830 CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K140807Composite Orthodontic BracketsOrtho Specialties · 2014 · cites it directly2descendants
- K113334Avex CX2 and Avex CXI2 Ceramic BracketsOpal Orthodontics by Ultradent Products, Inc. · 2012 · cites it directly1descendant
- K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbH · 2025 · cites it directly0descendants
- K201940Braces on Demand BracketBraces on Demand, Inc. · 2020 · 2 generations on0descendants
- K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973776 | Reflections | Cdb Corp. | 1997 | — |
| +1 | K140807 | Composite Orthodontic Brackets | Ortho Specialties | 2014 | — |
| +1 | K113334 | Avex CX2 and Avex CXI2 Ceramic Brackets | Opal Orthodontics by Ultradent Products, Inc. | 2012 | — |
| +1 | K251196 | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | 2025 | — |
| +2 | K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | 2020 | — |
| +2 | K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
3 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?
- Of its descendants, K140807 (Ortho Specialties, 2014) has gone furthest, with 2 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.
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?
Orthodontic brackets are usually cemented to the front surface of the tooth where they direct the mechanical forces that urge teeth into correct alignment. A curved arch wire that is bent or twisted to a particular prescription before installation is forced into a slot in each bracket. The resulting torque or restoring force causes the teeth to shift into the desired alignment. Depending on the shape and twist of the arch wire and the orientation of the…
Read the full statement (128 words)
Orthodontic brackets are usually cemented to the front surface of the tooth where they direct the mechanical forces that urge teeth into correct alignment. A curved arch wire that is bent or twisted to a particular prescription before installation is forced into a slot in each bracket. The resulting torque or restoring force causes the teeth to shift into the desired alignment. Depending on the shape and twist of the arch wire and the orientation of the bracket slot, it is possible to apply forces, which can shift, rotate, or tip the teeth in any desired direction.
Stainless steel, ceramic and plastic brackets are in common use. Plastic brackets are more aesthetically pleasing than the stainless steet which give a metallic smile. They are less expensive than ceramic.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973776: Reflections.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973776
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