# K013808: Sleepbite

- Pathway: 510(k) (Traditional)
- Applicant: Dental Imagineers, LLC
- Decided: Jan 30, 2002 after 76 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K880956 (1988). 4 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971794: Elastic Mandibular Advancement (Ema) Appliance, Frantz Design, Inc. (1997). Our OCR of the scanned summary read K971724, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Elastic Mandibular Appliance (EMA)”.
- K972424: Silentnite, Glidewell Laboratories (1997) Summary page 1.

## Most influential descendants
- 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
- K182312: Zyppah Anti-Snoring Device (2019), 3 descendants of its own

## Indications for use
SleepBite is prescribed for the patient by the healthcare professional. A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea. B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed following the appropriate testing for obstructive sleep apnea. C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.

Source page: https://510kreport.com/device/K013808
Methodology: https://510kreport.com/methodology