510(k) · Cleared
ClearedRemovable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · LRK Device, Anti-Snoring
Cleared on May 25, 2007 after a 109-day review. The FDA summary names its predicate without a number. 43 later devices descend from it.
- Decided
- May 25, 2007
- Review
- 109 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 5 citing it directly.
- This deviceK070327 Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch…Sybron Dental Specialties, Inc. · 2007
- Descendant · cites it directly · 38 of its ownK083209 Acrylic Herbst Splint ApplianceSpecialty Appliance Works, Inc. · 2009
- Descendant · 2 generations on · 29 of its ownK103076 DynaflexDyna Flex · 2011
- Descendant · 3 generations on · 17 of its ownK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK160234 OVENTOventus Manufacturing Pty, Ltd. · 2016
- Descendant · 4 generations on · 7 of its ownK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K083209Acrylic Herbst Splint ApplianceSpecialty Appliance Works, Inc. · 2009 · cites it directly38descendants
- K103076DynaflexDyna Flex · 2011 · 2 generations on29descendants
- K130130Atg/SM-Osa AppliancesSelane Products, Inc. · 2013 · 3 generations on17descendants
- K160234OVENTOventus Manufacturing Pty, Ltd. · 2016 · 3 generations on8descendants
- K161832O2VENT TOventus Manufacturing Pty, Ltd. · 2016 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| +3 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| +3 | K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| +4 | K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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 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? (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 |
|---|---|---|---|
| * | — | State University of New York at Buffalo, School of Dental Medicine, Removable Herbst… Named without a submission number | |
| * | — | Hays & Meade Inc., Snore Guard Named without a submission number | |
| * | — | Great Lakes Orthodontic Laboratory, NAPA Appliance Named without a submission number |
What descends from it? (43)
See all 435 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, K083209 (Specialty Appliance Works, Inc., 2009) has gone furthest, with 38 descendants of its own.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Enoch Snorinator is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070327 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070327: Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070327
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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