510(k) · Cleared
ClearedSilent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · LRK Device, Anti-Snoring
Cleared on Nov 14, 2023 as substantially equivalent to K210694 (Prismatik Dentalcraft, Inc., 2021) after a 32-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Nov 14, 2023
- Review
- 32 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K070327 (2007). No later device cites it as a predicate yet.
- Root · 4 generations backK070327 Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch…Sybron Dental Specialties, Inc. · 2007
- 3 generations backK083209 Acrylic Herbst Splint ApplianceSpecialty Appliance Works, Inc. · 2009
- 2 generations backK183270 Silent Nite slPrismatik Dentalcraft, Inc. · 2019 · Recalled
- 1 generation backK210694 Silent Nite Sleep Appliance with the Glidewell HingePrismatik Dentalcraft, Inc. · 2021
- This deviceK233434 Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator | Sybron Dental Specialties, Inc. | 2007 | — |
| −3 | K083209 | Acrylic Herbst Splint Appliance | Specialty Appliance Works, Inc. | 2009 | — |
| −2 | K183270 | Silent Nite sl | Prismatik Dentalcraft, Inc. | 2019 | 1 |
| −1 | K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. | 2021 | — |
| 0 (this device) | K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) | Prismatik Dentalcraft, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K210694 | Silent Nite Sleep Appliance with the Glidewell HingeSummary page 5…vices for snoring and obstructive sleep apnea Regulation Number: 872.5570 Product Code: LRK Legally Marketed Predicate Device (21 CFR 807.92(a)(3)) Predicate 510(k) #: K210694 Predicate Trade Name: Silent Nite Sleep Appliance with the Glidewell Hinge Product Code: LRK Device Description Summary (21 CFR… | 2021 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to
moderate obstructive sleep apnea (OSA) in adults 18 years of age or older. It 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/K233434 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233434: Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233434
Report an extraction error
Are you the manufacturer?
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