# K972424: Silentnite

- Pathway: 510(k) (Traditional)
- Applicant: Glidewell Laboratories
- Decided: Sep 18, 1997 after 83 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SILENCER by Silent Knights Ventures, Inc.: named in the summary without a submission number
- (no number) THERASNORE by Dr. Thomas E. Meade: named in the summary without a submission number
- (no number) PM POSITIONER by Dental Services Group: named in the summary without a submission number
- (no number) KLEARWAY by Great Lakes Orthodontics: named in the summary without a submission number
- (no number) SNOREFREE by Space Maintainers Laboratory: named in the summary without a submission number
- (no number) SNORNOMORE by Annalan Labs: named in the summary without a submission number
- (no number) “Z” by “Z” Training: named in the summary without a submission number

## Most influential descendants
- K013808: Sleepbite (2002), 11 descendants of its own
- K052862: Full Breath Sleep Appliance - AB (Anterior Bite) (2005), 9 descendants of its own
- K061228: Full Breath Sleep Appliance with Posterior Tongue Depressor (2006), 8 descendants of its own
- K091035: Full Breath Sleep Appliance Lower (FBSL) (2009), 7 descendants of its own
- K111680: DR. Greensburg's Hybrid (2011), 6 descendants of its own

## Recalls of this device
- Apr 27, 2026 · Class II · Z-2769-2026: Due to device not having FDA Clearance

## Indications for use
The SilentNite™ mandibular repositioning (MRP) device is indicated for persons who wish to prevent snoring and is available only from a dentist by prescription. It has been estimated that 6 million or more adults (with men outnumbering women 8 to 1) snores, and that 10% may have sleep apnea. If an examination of the patient, together with the patient’s responses to a questionnaire, indicate the possibility of a more serious sleep disorder than “primary” or “social” snoring, the patient should be referred to a physician who can diagnose sleep apnea based on testing in a sleep laboratory and suggest treatment options. Necessary treatment for serious cases of sleep apnea may include surgery, or a medically prescribed treatment called nasal continuous positive airway pressure, or a MRP device. MRP devices may be appropriate treatment for persons with mild sleep apnea swhen surgical and other medical treatments are ineffective or not desired. Contraindications for use: Based on the dentists examination and the patient’s responses the questionnaire, obstructive sleep apnea may either be indicated or cannot be excluded. In such event, an examination by a sleep disorder specialist is recommended before prescribing the SilentNite™ snoring device. If the dentist’s examination and the patient’s responses to the questionnaire indicate the possibility of disease or injury to the mandibular joint, the SilentNite™ snoring device is contraindicated and should not be prescribed, to avoid the possibility of further damage to the mandibular joint.

Source page: https://510kreport.com/device/K972424
Methodology: https://510kreport.com/methodology