510(k) · Cleared
ClearedOptiflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corp. · EJF Bracket, Metal, Orthodontic
Cleared on Sep 15, 1989 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Sep 15, 1989
- Review
- 49 days
- Class
- Class I
- Product code
- EJF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK894781 OptiflexOrmco Corp. · 1989
- Descendant · cites it directly · 2 of its ownK081143 Biomers Translucent Orthodontic WireBiomers Product, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK110796 Simpliclear Rectangular Orthodontic WireBiomers Products, LLC · 2011
- Descendant · 3 generations on · 0 of its ownK150830 CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016
Most influential descendants
Showing 3 of 3 · See all- K081143Biomers Translucent Orthodontic WireBiomers Product, LLC · 2008 · cites it directly2descendants
- K110796Simpliclear Rectangular Orthodontic WireBiomers Products, LLC · 2011 · 2 generations on1descendant
- K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894781 | Optiflex | Ormco Corp. | 1989 | — |
| +1 | K081143 | Biomers Translucent Orthodontic Wire | Biomers Product, LLC | 2008 | — |
| +2 | K110796 | Simpliclear Rectangular Orthodontic Wire | Biomers Products, LLC | 2011 | — |
| +3 | K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EJF? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081143 | Biomers Translucent Orthodontic Wire | 2008 | 2 |
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, K081143 (Biomers Product, LLC, 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EJF devicesEJF Bracket, Metal, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJF
FDA has decided no EJF device since 2007.
Median 510(k) review, days · EJF
Too few EJF 510(k)s in any year since 2007 to give a median.
Recalls per year · EJF
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EJF
3in 2025
MAUDE reports naming product code EJF, 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 | 2 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 1 | 19 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 1 | 5 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K894781 · printed Nov 5, 2026
Cite this page
510(k) Report. “K894781: Optiflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894781
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026