# K991948: DR. B'S Mouthpiece, Model 32129-10002

- Pathway: 510(k) (Traditional)
- Applicant: Snore - Ezzer
- Decided: Sep 2, 1999 after 85 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
No predicates in its family tree.
76 later devices descend from it; 4 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022891: The Breathe EZ Anti-Snoring Device (2003), 75 descendants of its own
- K030440: Oasys-Oral Airway System (2003), 65 descendants of its own
- K060388: Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment (2006), 51 descendants of its own
- K061732: TAP-T (2006), 32 descendants of its own
- K103076: Dynaflex (2011), 29 descendants of its own

## Indications for use
To Alleviate or correct simple snoring by maintaining an open airway during sleep and to prevent bruxing and grinding of teeth.

Source page: https://510kreport.com/device/K991948
Methodology: https://510kreport.com/methodology