# K062333: Laimad

- Pathway: 510(k) (Abbreviated)
- Applicant: Steven Lamberg, D.D.S
- Decided: Dec 14, 2006 after 126 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 K011560 (2001). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973038: Adjustable Therasnore, Distar, Inc. (1997) Summary page 1.
- K011560: Trubyte Denture Base Resin System, Dentsply Intl. (2001)
- K032892: Modification to Trubyte Denture Base Resin System, Dentsply Intl. (2003) Summary page 1.
- (no number) Hawley retainer: named in the summary without a submission number

## Most influential descendants
- K101155: Auradorm (Neuromuscular Sleep) (2011), 0 descendants of its own
- K101709: Lambergsleepwell- Smartrusion (LSW-S) (2010), 0 descendants of its own

## Indications for use
The Lamberg Sleep Well device is intended to reduce night time snoring in adults 18 years of age or older in a home or sleep laboratory environment. The device must be prescribed by a dentist or physician.

Source page: https://510kreport.com/device/K062333
Methodology: https://510kreport.com/methodology