510(k) · Cleared
ClearedOrthocad IQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadent, Inc. · DYW Bracket, Plastic, Orthodontic
Cleared on Oct 23, 2009 after a 444-day review. The FDA summary names its predicate without a number. 44 later devices descend from it.
- Decided
- Oct 23, 2009
- Review
- 444 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 4 citing it directly.
- This deviceK082207 Orthocad IQCadent, Inc. · 2009
- Descendant · cites it directly · 33 of its ownK152086 3Shape Ortho System3Shape A/S · 2016
- Descendant · 2 generations on · 14 of its ownK171634 Ortho System3Shape A/S · 2018
- Descendant · 2 generations on · 13 of its ownK171295 ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018
- Descendant · 3 generations on · 8 of its ownK180941 Ortho System3Shape A/S · 2018
- Descendant · 2 generations on · 5 of its ownK171122 CEREC Ortho SoftwareDentsply Sirona · 2018
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K1520863Shape Ortho System3Shape A/S · 2016 · cites it directly33descendants
- K171634Ortho System3Shape A/S · 2018 · 2 generations on14descendants
- K171295ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018 · 2 generations on13descendants
- K180941Ortho System3Shape A/S · 2018 · 3 generations on8descendants
- K171122CEREC Ortho SoftwareDentsply Sirona · 2018 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| +1 | K152086 | 3Shape Ortho System | 3Shape A/S | 2016 | — |
| +2 | K171634 | Ortho System | 3Shape A/S | 2018 | — |
| +2 | K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018 | — |
| +3 | K180941 | Ortho System | 3Shape A/S | 2018 | — |
| +2 | K171122 | CEREC Ortho Software | Dentsply Sirona | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 9 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | — | Cadent Inc.'s OrthoCAD System Named without a submission number | |
| * | — | Align Technologies, Inc.'s Invisalign System Named without a submission number | |
| * | — | OraMetrix, Inc.'s SureSmile System Named without a submission number |
What descends from it? (44)
See all 444 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, K152086 (3Shape A/S, 2016) has gone furthest, with 33 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. 2009, 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?
OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082207 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082207: Orthocad IQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082207
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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