510(k) · Cleared
ClearedREST EAZY Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insert Molding Solutions, Inc. · LRK Device, Anti-Snoring
Cleared on Mar 26, 2018 as substantially equivalent to K083209 (Specialty Appliance Works, Inc., 2009) after a 194-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Mar 26, 2018
- Review
- 194 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070327 (2007). No later device cites it as a predicate yet.
- Root · 2 generations backK070327 Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch…Sybron Dental Specialties, Inc. · 2007
- 1 generation backK083209 Acrylic Herbst Splint ApplianceSpecialty Appliance Works, Inc. · 2009
- This deviceK172760 REST EAZY ApplianceInsert Molding Solutions, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator | Sybron Dental Specialties, Inc. | 2007 | — |
| −1 | K083209 | Acrylic Herbst Splint Appliance | Specialty Appliance Works, Inc. | 2009 | — |
| 0 (this device) | K172760 | REST EAZY Appliance | Insert Molding Solutions, Inc. | 2018 | — |
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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 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 |
|---|---|---|---|
| * | K083209 | Acrylic Herbst Splint ApplianceSummary page 5…REST EAZY Appliance IV. Predicate Device • Specialty Appliance Works, Inc.’s Acrylic Splint Herbst Appliance o K083209 (Specialty Appliance Works, Inc), FDA cleared on 01/27/2009 V. Reference Devices • Embassy Dental Laboratory’s Acrylic H… | 2009 |
| † | K111009 | Acrylic Herbst Appliance | 2011 |
| † | K162816 | SML-OSA2 Appliances | 2017 |
| † | K033632 | Variflex | 2004 |
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 11 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K083209.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The REST EAZY Appliance is intended for use in adult patients for the reduction of snoring and mild to moderate obstructive sleep apnea. The REST EAZY Appliance is worn while sleeping to support the lower jaw in a forward position as prescribed by the dentist. The appliance is removable by the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172760: REST EAZY Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172760
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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