510(k) · Cleared
ClearedHyperelastic Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corp. · DZC Wire, Orthodontic
Cleared on Nov 16, 2011 after a 65-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 16, 2011
- Review
- 65 days
- Class
- Class I
- Product code
- DZC
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DZC? 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? (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 |
|---|---|---|---|
| * | — | CuTiNi Wire 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.
How does its category compare?
All DZC devicesDZC Wire, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DZC
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · DZC
Too few DZC 510(k)s in any year since 2007 to give a median.
Recalls per year · DZC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZC
1in 2025
MAUDE reports naming product code DZC, 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 | 33 |
| 2008 | 0 | — | 0 | 143 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 2 | 5 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelastic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112640: Hyperelastic Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112640
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026