510(k) · Cleared
ClearedSilent Nite Sleep Appliance with the Glidewell Hinge
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 Jun 16, 2021 as substantially equivalent to K183270 (Prismatik Dentalcraft, Inc., 2019) after a 100-day review. Its family tree reaches back 3 generations to 2007. 1 later device descends from it.
- Decided
- Jun 16, 2021
- Review
- 100 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070327 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK070327 Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch…Sybron Dental Specialties, Inc. · 2007
- 2 generations backK083209 Acrylic Herbst Splint ApplianceSpecialty Appliance Works, Inc. · 2009
- 1 generation backK183270 Silent Nite slPrismatik Dentalcraft, Inc. · 2019 · Recalled
- This deviceK210694 Silent Nite Sleep Appliance with the Glidewell HingePrismatik Dentalcraft, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK233434 Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K233434Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator | Sybron Dental Specialties, Inc. | 2007 | — |
| −2 | K083209 | Acrylic Herbst Splint Appliance | Specialty Appliance Works, Inc. | 2009 | — |
| −1 | K183270 | Silent Nite sl | Prismatik Dentalcraft, Inc. | 2019 | 1 |
| 0 (this device) | K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. | 2021 | — |
| +1 | K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) | Prismatik Dentalcraft, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 |
|---|---|---|---|
| * | K183270 | Silent Nite slSummary page 4…for obstructive sleep apnea and Number 21 CFR 872.5570 Product Code LRK Regulatory Class II Primary Predicate K183270, Silent Nite sl, Prismatik Dentalcraft, Inc. (LRK) Device: Reference Devices Reference #1: K200125, Thermoforming… | 2019 |
| † | K200125 | Thermoforming Sheet Materials | 2020 |
| † | K083209 | Acrylic Herbst Splint Appliance | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) | 2023 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K233434 (Prismatik Dentalcraft, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K183270.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 patients 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210694: Silent Nite Sleep Appliance with the Glidewell Hinge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210694
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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