510(k) · Cleared
ClearedSimpliclear Rectangular Orthodontic Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomers Products, LLC · DYW Bracket, Plastic, Orthodontic
Cleared on Mar 31, 2011 as substantially equivalent to K081143 (Biomers Product, LLC, 2008) after a 9-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Mar 31, 2011
- Review
- 9 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894781 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894781 OptiflexOrmco Corp. · 1989
- 1 generation backK081143 Biomers Translucent Orthodontic WireBiomers Product, LLC · 2008
- This deviceK110796 Simpliclear Rectangular Orthodontic WireBiomers Products, LLC · 2011
- Descendant · cites it directly · 0 of its ownK150830 CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016
Most influential descendants
Showing 1 of 1 · See all- K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894781 | Optiflex | Ormco Corp. | 1989 | — |
| −1 | K081143 | Biomers Translucent Orthodontic Wire | Biomers Product, LLC | 2008 | — |
| 0 (this device) | K110796 | Simpliclear Rectangular Orthodontic Wire | Biomers Products, LLC | 2011 | — |
| +1 | K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K081143 | Biomers Translucent Orthodontic WireSummary page 2…We Mike I~ii Sinil BioMers Trans lucent Orthodontic Wire was cleared by the FDA on May 2, 2008 under 5 10(k) K08 1143. The Ormco wires are exempt from 5 10(k) filings. W,~&t1~9>Y p.iiisfldiictiLsLC-.… | 2008 |
| * | — | Ormco Rectangular Orthodontic Wire composed of Nickel Titanium, beta-Titanium, and… Named without a submission number |
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 |
|---|---|---|---|
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | 2016 | 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 18.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150830 (Oracrew, 2016) 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. 2011, 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?
An orthodontic archwire used to provide force to the teeth to effect movement in orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110796 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110796: Simpliclear Rectangular Orthodontic Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110796
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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