FULL BREATH SLEEP APPLIANCE LOWER (FBSL)

• K Number: K091035
• Device Name: FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
• Manufacturer: BRYAN KEROPIAN DDS
• Date Cleared: 2009-06-24 ( 75 days)
• Product Code: LQZ
• Regulation Number: 872.5570
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K061228 , K032410 , K052862

Intended Use

1. Full Breath Sleep Appliance Lower- This appliance is indicated for the treatment of snoring.
2. Full Breath Sleep Appliance Lower This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.

Device Description

The Full Breath Soution Lower is a custom fabricated device which is typically done by a professional dental laboratory and delivered by a dentist.

AI/ML Overview

There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA letter for a PREDICATE DEVICE COMPARISON TABLE:
dental appliance, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against specific acceptance criteria.

The document indicates that "All the research and data gathered for 510(k) K061228 are applicable for this application for certification," referring to a previously cleared device. However, the details of that prior research and data, including acceptance criteria and study particulars, are not included in the provided text.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study that proves the device meets them based on the given information.

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
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.(b)
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.”