Full Breath Sleep Appliance With Posterior Tongue Depressor
510(k) K061228
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061228 | Date26 May 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LQZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5570
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a custom-fitted intraoral jaw repositioning appliance, classified as a dental device. It incorporates an anterior bite component and a posterior tongue depressor/restrainer to manage airway obstruction, primarily indicated for patients with snoring and mild-to-moderate obstructive sleep apnea (OSA).
The appliance is designed for use under physician supervision and is supplied as a custom-fitted, single-patient device. It is regulated under FDA 510(k) clearance (K061228) and falls under the classification of Class II medical devices (regulation number 872.5570). No third-party reprocessing is indicated, and its use is restricted to dental applications as per the advisory committee classification.
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Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Full Breath Sleep Appliance with Posterior Tongue Depressor?
This device is designed as a custom-fitted intraoral jaw repositioning appliance to manage airway obstruction in patients with snoring and mild-to-moderate obstructive sleep apnea (OSA). It combines an anterior bite component with a posterior tongue depressor/restrainer to help maintain an open airway during sleep, improving breathing patterns.
Is this appliance reusable or intended for single-patient use?
The Full Breath Sleep Appliance is supplied as a single-patient-use device, meaning it is custom-fitted for one individual only. The manufacturer explicitly states it is not intended for third-party reprocessing or reuse, ensuring patient-specific safety and hygiene.
How is the device regulated, and what does that mean for clinicians?
This appliance is classified as a Class II medical device under FDA regulation number 872.5570 and holds a 510(k) clearance (K061228). This means it has undergone FDA review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for dental use under physician supervision.
Are there different sizes or models available for this device?
The device is custom-fitted per patient, so no standardized sizes are pre-manufactured. Each appliance is fabricated based on an individual’s dental impressions to ensure proper alignment and functionality. The listed OpenFDA registration numbers reflect various patient-specific devices, confirming its tailored approach.
What storage or handling instructions should be followed for this appliance?
Since the appliance is single-use and custom-fitted, storage instructions are primarily for unopened, sterile packaging until use. The manufacturer does not specify post-use storage, but standard dental practice would recommend proper cleaning and disposal per facility protocols. Always follow the clinician’s guidance for handling and patient-specific instructions.