510(k) · Cleared
ClearedDental Arch Bar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unisplint Corp. · DYX Lock, Wire, And Ligature, Intraoral
Cleared on May 5, 1982 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- May 5, 1982
- Review
- 29 days
- Class
- Class II
- Product code
- DYX
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 4 citing it directly.
- This deviceK820944 Dental Arch BarUnisplint Corp. · 1982
- Descendant · cites it directly · 25 of its ownK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
- Descendant · cites it directly · 15 of its ownK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- Descendant · cites it directly · 14 of its ownK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- Descendant · cites it directly · 13 of its ownK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- Descendant · 2 generations on · 11 of its ownK050535 Stryker MMF ScrewStryker Instruments · 2005
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K963030Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997 · cites it directly25descendants
- K991004Synthes Quick Lock Imf SystemSynthes (Usa) · 1999 · cites it directly15descendants
- K031207Safety Release Arch Bar KitCasey Surgical, LLC · 2003 · cites it directly14descendants
- K061271Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006 · cites it directly13descendants
- K050535Stryker MMF ScrewStryker Instruments · 2005 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| +1 | K963030 | Leibinger Imf Screw | Howmedica Leibinger, Inc. | 1997 | — |
| +1 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| +1 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| +1 | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| +2 | K050535 | Stryker MMF Screw | Stryker Instruments | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 DYX? 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? (31)
See all 314 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, K963030 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 25 descendants of its own.
How does its category compare?
All DYX devicesDYX Lock, Wire, And Ligature, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DYX
Too few DYX 510(k)s in any year since 2007 to give a median.
Recalls per year · DYX
No recall names DYX since 2007.
Adverse event reports per year · DYX
1in 2016
MAUDE reports naming product code DYX, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K820944 · printed Nov 5, 2026
Cite this page
510(k) Report. “K820944: Dental Arch Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K820944
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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