510(k) · Cleared
ClearedCompleClear Plastic Orthodontic Bracket and Wire Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oracrew · DYW Bracket, Plastic, Orthodontic
Cleared on Aug 26, 2016 as substantially equivalent to K110796 (Biomers Products, LLC, 2011) and 1 other predicate after a 515-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Aug 26, 2016
- Review
- 515 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K852179 (1985). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 5 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 4 generations backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- 3 generations backK090454 Allure MB Ceramic BracketsDentsply Interntional · 2009
- 2 generations backK092030 Elation MB Metal Reinforced Plastic BracketDentsply Interntional · 2009
- 1 generation backK140807 Composite Orthodontic BracketsOrtho Specialties · 2014
- This deviceK150830 CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −5 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −4 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| −3 | K090454 | Allure MB Ceramic Brackets | Dentsply Interntional | 2009 | — |
| −2 | K092030 | Elation MB Metal Reinforced Plastic Bracket | Dentsply Interntional | 2009 | — |
| −1 | K140807 | Composite Orthodontic Brackets | Ortho Specialties | 2014 | — |
| 0 (this device) | K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K110796 | Simpliclear Rectangular Orthodontic WireSummary page 6…for Use: CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth. Predicate Device: K110796 Biomers SimpliClear Rectangular Orthodontic Wire and K140807 Ortho Specialties Incorporated Composite Brackets Substantial Equiv… | 2011 |
| * | K140807 | Composite Orthodontic BracketsSummary page 6…ar, plastic bracket and archwire system to provide orthodontic movement of natural teeth. Predicate Device: K110796 Biomers SimpliClear Rectangular Orthodontic Wire and K140807 Ortho Specialties Incorporated Composite Brackets Substantial Equivalence: CompleClear is substantially equivalent to Ortho Spec… | 2014 |
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.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 11 ancestors has a recall.
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?
CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.
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/K150830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150830: CompleClear Plastic Orthodontic Bracket and Wire Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150830
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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