510(k) · Cleared
ClearedAtg/SM-Osa Appliances
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Selane Products, Inc. · LQZ Device, Jaw Repositioning
Cleared on Aug 26, 2013 as substantially equivalent to K103076 (Dyna Flex, 2011) after a 221-day review. Its family tree reaches back 8 generations to 1989. 17 later devices descend from it.
- Decided
- Aug 26, 2013
- Review
- 221 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K882303 (1989). 16 ancestors in all. 17 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 6 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 5 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 4 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 3 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 2 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 1 generation backK103076 DynaflexDyna Flex · 2011
- This deviceK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- Descendant · 2 generations on · 5 of its ownK191320 Slow Wave DS8Slow Wave, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK130067 Mrna ApplianceBiomodeling Solutions, Lls · 2014
- Descendant · 2 generations on · 2 of its ownK222872 DNA ApplianceVivos Therapeutics, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK233754 AIO BreatheAiomega, LLC · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020 · cites it directly6descendants
- K191320Slow Wave DS8Slow Wave, Inc. · 2020 · 2 generations on5descendants
- K130067Mrna ApplianceBiomodeling Solutions, Lls · 2014 · cites it directly5descendants
- K222872DNA ApplianceVivos Therapeutics, Inc. · 2022 · 2 generations on2descendants
- K233754AIO BreatheAiomega, LLC · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −7 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −6 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −5 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −4 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −3 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −2 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −1 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| 0 (this device) | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| +1 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020 | — |
| +2 | K191320 | Slow Wave DS8 | Slow Wave, Inc. | 2020 | — |
| +1 | K130067 | Mrna Appliance | Biomodeling Solutions, Lls | 2014 | — |
| +2 | K222872 | DNA Appliance | Vivos Therapeutics, Inc. | 2022 | — |
| +3 | K233754 | AIO Breathe | Aiomega, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 LQZ? 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 LQZ device
- #1 K233754 AIO Breathescore 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K103076 | DynaflexSummary page 1…ME: ATG/SM-OSA APPLIANCES CLASSIFICATION NAME: lntraoral devices for snoring and obstructive sleep apnea: CFR 872.5570, Product Code LQZ &LRK PREDICATE DEVICE: K(103076 DEVICE DESCRIPTION: The ATG/SM-OSA APPLIANCES are primarily polymer trays that are used intraorally over the dentition to make t… | 2011 |
What descends from it? (17)
See all 176 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 8 companies; a new generation was cleared every 2.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K192581 (Advanced Facialdontics, LLC, 2020) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K103076.
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LQZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LQZ
Too few LQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LQZ
No recall names LQZ since 2007.
Adverse event reports per year · LQZ
2in 2021
MAUDE reports naming product code LQZ, 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 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ATG/SM-OSA appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The ATG/SM-OSA appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130130: Atg/SM-Osa Appliances.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130130
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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