510(k) · Cleared
ClearedSymetri Clear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corporation · NJM Bracket, Ceramic, Orthodontic
Cleared on Jan 31, 2018 as substantially equivalent to K102803 (3M Unitek Corporation, 2011) and 1 other predicate after a 134-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Jan 31, 2018
- Review
- 134 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K852179 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 3 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 2 generations backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- 1 generation backK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- This deviceK172845 Symetri ClearOrmco Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −3 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −2 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| −1 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| 0 (this device) | K172845 | Symetri Clear | Ormco Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 NJM? 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 NJM device
- #1 K222764 LightForce Orthodontic Systemscore 8.5 · 6 generations · 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 |
|---|---|---|---|
| * | K102803 | Clarity Advanced Ceramic BracketsSummary page 4…edical Device, Class II 6. Predicate Device Symetri Clear™ is substantially equivalent to 3M Unitek Corporation’s Clarity™ ADVANCED Ceramic Brackets (K102803) cleared on February 17, 2011, product code NJM. 7. Reference Predicate Device Damon™ 4Clear, K081415 === Pa… | 2011 |
| * | K081415 | Damon 4CLEARSummary page 4…on’s Clarity™ ADVANCED Ceramic Brackets (K102803) cleared on February 17, 2011, product code NJM. 7. Reference Predicate Device Damon™ 4Clear, K081415 8. Device Description Symetri Clear, is a single-use orthodontic bracket made from polycrystalline alum… | 2008 |
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 33 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- None of the 8 ancestors has a recall.
- 6 other devices also cite its predicate K102803.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NJM
5in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NJM
1in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NJM
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJM
1in 2025
MAUDE reports naming product code NJM, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 61 | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 4 | 122 | 0 | 1 |
| 2012 | 6 | 90 | 0 | 1 |
| 2013 | 3 | 123 | 1 | 6 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 234 | 0 | 0 |
| 2016 | 3 | 176 | 0 | 2 |
| 2017 | 3 | 183 | 0 | 2 |
| 2018 | 4 | 76 | 0 | 2 |
| 2019 | 6 | 200 | 0 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 5 | 1 | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172845: Symetri Clear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172845
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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