510(k) · Cleared
ClearedAcrylic Herbst Splint Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Appliance Works, Inc. · LRK Device, Anti-Snoring
Cleared on Jan 27, 2009 as substantially equivalent to K070327 (Sybron Dental Specialties, Inc., 2007) after an 88-day review. Its family tree reaches back 1 generation to 2007. 38 later devices descend from it.
- Decided
- Jan 27, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070327 (2007). 38 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK070327 Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch…Sybron Dental Specialties, Inc. · 2007
- This deviceK083209 Acrylic Herbst Splint ApplianceSpecialty Appliance Works, Inc. · 2009
- Descendant · cites it directly · 29 of its ownK103076 DynaflexDyna Flex · 2011
- Descendant · 2 generations on · 17 of its ownK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK160234 OVENTOventus Manufacturing Pty, Ltd. · 2016
- Descendant · 3 generations on · 7 of its ownK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
- Descendant · 3 generations on · 6 of its ownK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K103076DynaflexDyna Flex · 2011 · cites it directly29descendants
- K130130Atg/SM-Osa AppliancesSelane Products, Inc. · 2013 · 2 generations on17descendants
- K160234OVENTOventus Manufacturing Pty, Ltd. · 2016 · 2 generations on8descendants
- K161832O2VENT TOventus Manufacturing Pty, Ltd. · 2016 · 3 generations on7descendants
- K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator | Sybron Dental Specialties, Inc. | 2007 | — |
| 0 (this device) | K083209 | Acrylic Herbst Splint Appliance | Specialty Appliance Works, Inc. | 2009 | — |
| +1 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| +2 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| +2 | K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| +3 | K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| +3 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch SnorinatorSummary page 1…• Device Class - II Devices for Which Substantial Eguivalence is claimed: *Allesee Orthodontic Appliances, Inc. - Removable Acrylic Herbst (K0703 27) Page 5-1 4905 Hammnond Industr… | 2007 |
| † | K033632 | Variflex | 2004 |
What descends from it? (38)
See all 387 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?
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea. The Acrylic Splint Herbst Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083209: Acrylic Herbst Splint Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083209
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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