Who is the manufacturer of GOOD NIGHT?

Larry V Connell, Dmd submitted the Abbreviated clearance for GOOD NIGHT (K102463).

What is the FDA product code for GOOD NIGHT?

LRK. It is classified under 21 CFR 872.5570 as a Class 2 device in the Dental panel.

What is the regulatory pathway for GOOD NIGHT?

510(k) clearance (submission type: Abbreviated).

GOOD NIGHT

K102463 · Larry V Connell, Dmd · LRK · May 25, 2011 · Dental

Device Facts

Record ID	K102463
Device Name	GOOD NIGHT
Applicant	Larry V Connell, Dmd
Product Code	LRK · Dental
Decision Date	May 25, 2011
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.5570
Device Class	Class 2

Regulatory Classification

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”