510(k) · Cleared
ClearedIst Snoring Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Crafters · LQZ Device, Jaw Repositioning
Cleared on Sep 11, 2009 as substantially equivalent to K072731 (Dockstader Orthodontic Lab, Inc., 2008) and 2 other predicates after a 163-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Sep 11, 2009
- Review
- 163 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K882303 (1989). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 5 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 4 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 3 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 2 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 1 generation backK062951 Tap Iii Anti-Snoring DeviceAirway Management, Inc. · 2006
- This deviceK090911 Ist Snoring ApplianceDental Crafters · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −6 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −5 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −4 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −3 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −2 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −1 | K062951 | Tap Iii Anti-Snoring Device | Airway Management, Inc. | 2006 | — |
| 0 (this device) | K090911 | Ist Snoring Appliance | Dental Crafters | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 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 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? (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 |
|---|---|---|---|
| * | K072731 | EndsnorSummary page 2…equivalent to other legally marketed Anti-Snoring Devices. Specifically, the Dental Crafters' IST Snoring Appliance is substantially equivalent to Endsnor (K07273 1), Removable Arylic Herbst Allesee Snore (K070327), and TAP III (K062951). IST has the same general intended use, similar… | 2008 |
| * | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch SnorinatorSummary page 2…Devices. Specifically, the Dental Crafters' IST Snoring Appliance is substantially equivalent to Endsnor (K07273 1), Removable Arylic Herbst Allesee Snore (K070327), and TAP III (K062951). IST has the same general intended use, similar principles of operation, and similar technological… | 2007 |
| * | K062951 | Tap Iii Anti-Snoring DeviceSummary page 2…the Dental Crafters' IST Snoring Appliance is substantially equivalent to Endsnor (K07273 1), Removable Arylic Herbst Allesee Snore (K070327), and TAP III (K062951). IST has the same general intended use, similar principles of operation, and similar technological characteristics as the… | 2006 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- None of the 14 ancestors has a recall.
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 IST Snoring Appliance is a dentist prescribed intraoral device for repositioning the upper and lower jaw into a prescribed relationship in single patient for multi-use at home or sleep laboratories. It is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090911 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090911: Ist Snoring Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090911
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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