# K052862: Full Breath Sleep Appliance - AB (Anterior Bite)

- Pathway: 510(k) (Traditional)
- Applicant: Bryan Keropian Dds
- Decided: Dec 30, 2005 after 80 days
- Product code: LQZ (Device, Jaw Repositioning)
- 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: 4 generations back to K882303 (1989). 15 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032410: Snorenti, James P Boyd (2005) Summary page 2.
- K010876: Nti Tension Suppression System, Nti-Tss, Inc. (2001) Summary page 2.
- K022891: The Breathe EZ Anti-Snoring Device, D&S Redhage (2003) Summary page 2.
- K013808: Sleepbite, Dental Imagineers, LLC (2002). Our reading of the summary gave K103808, FDA’s number for Sapphire NC (Orbusneich Medical, Inc.), decided Sep 1, 2011, after this device. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Sleepbite”.
- K991948: DR. B'S Mouthpiece, Model 32129-10002, Snore - Ezzer (1999)

## Most influential descendants
- 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
- K252531: Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (2026), 1 descendant of its own

## Indications for use
1. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea. 2. For the treatment of snoring. 3. For the prevention of bruxism.

Source page: https://510kreport.com/device/K052862
Methodology: https://510kreport.com/methodology