510(k) · Cleared
ClearedErch Arch Bar, Model 38-690-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · DYX Lock, Wire, And Ligature, Intraoral
Cleared on Jun 30, 2006 as substantially equivalent to K031207 (Casey Surgical, LLC, 2003) and 3 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1982. 13 later devices descend from it.
- Decided
- Jun 30, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- DYX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K820944 (1982). 5 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 2 generations backK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- 1 generation backK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- This deviceK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- Descendant · cites it directly · 10 of its ownK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
- Descendant · cites it directly · 5 of its ownK143336 Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015
- Descendant · 2 generations on · 4 of its ownK141165 Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK173320 KLS Martin L1 MMF SystemKLS Martin L.P. · 2018
- Descendant · 3 generations on · 1 of its ownK241314 KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K122313Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012 · cites it directly10descendants
- K143336Biomet Microfixation OmniMax MMF SystemBiomet Microfixation · 2015 · cites it directly5descendants
- K141165Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014 · 2 generations on4descendants
- K173320KLS Martin L1 MMF SystemKLS Martin L.P. · 2018 · 2 generations on2descendants
- K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −2 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| −1 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| 0 (this device) | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| +1 | K122313 | Stryker Universal Smartlock Hybrid MMF System | Stryker | 2012 | — |
| +1 | K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015 | — |
| +2 | K141165 | Matrixwave MMF System | Synthes (USA) Products, LLC | 2014 | — |
| +2 | K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | 2018 | — |
| +3 | K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 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? (4)
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 |
|---|---|---|---|
| * | K031207 | Safety Release Arch Bar KitSummary page 1…Lock, Wire, and Ligature, Intraoral (CFR 872.4600) Regulatory Class: 1I Predicate Devices: Safety Release Arch Bar Kit (K031 207) Aragon Wiring System Wire Cartridge (K0228211)… | 2003 |
| * | K022821 | Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire…Summary page 1…1I Predicate Devices: Safety Release Arch Bar Kit (K031 207) Aragon Wiring System Wire Cartridge (K0228211) Synthes; Quick Lock IMF System (K991004) Dental Arch Bar (K820944) Intende… | 2002 |
| * | K991004 | Synthes Quick Lock Imf SystemSummary page 1…Aragon Wiring System Wire Cartridge (K0228211) Synthes; Quick Lock IMF System (K991004) Dental Arch Bar (K820944) Intended Use: The Erich Arch Bar is indicated for use in… | 1999 |
| * | K820944 | Dental Arch BarSummary page 1…Wire Cartridge (K0228211) Synthes; Quick Lock IMF System (K991004) Dental Arch Bar (K820944) Intended Use: The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandib… | 1982 |
What descends from it? (13)
See all 133 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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122313 (Stryker, 2012) has gone furthest, with 10 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 | — |
What is it indicated for?
The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061271: Erch Arch Bar, Model 38-690-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061271
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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