Advanced Dental Applicance
by Dasoft Partners 510(k)
Active
510(k) K172991
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172991 | Date10 Jul 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LRK
- 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
The Advanced Dental Appliance LRK is a Device, Anti-Snoring (per FDA nomenclature), designed to reduce snoring in adult patients aged 18 years or older. It functions as a dental device intended to reposition the mandible or tongue to alter airway anatomy and minimize obstructive sleep apnea-related snoring.
This device is supplied as a single-use or reusable (as determined by manufacturer specifications) and is classified under FDA regulation 872.5570 as a Class II medical device. It has received FDA 510(k) clearance (K172991, K203462) under an Abbreviated submission process, with no explicit MRI safety or sterility requirements stated in the regulatory data. Distribution is managed by Dasoft Partners, based in San Diego, CA.
Other devices from Dasoft Partners
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Advanced Dental Appliance LRK and who is it intended for?
The Advanced Dental Appliance LRK is designed to reduce snoring in adult patients aged 18 years or older by repositioning the mandible or tongue to alter airway anatomy. It is specifically intended for use in minimizing obstructive sleep apnea-related snoring, as classified under FDA nomenclature for anti-snoring devices.
Is the Advanced Dental Appliance LRK single-use or reusable, and how should it be handled?
The Advanced Dental Appliance LRK can be supplied as either single-use or reusable, depending on the manufacturer’s specifications. Since no explicit sterility requirements are mentioned in the regulatory data, handling should follow manufacturer guidelines to ensure proper cleaning, disinfection (if reusable), and storage to maintain safety and efficacy.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Advanced Dental Appliance LRK received FDA 510(k) clearance through an Abbreviated submission process, with clearance numbers K172991 and K203462. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. without additional approvals beyond this clearance.
Are there any specific storage instructions or considerations for the Advanced Dental Appliance LRK?
The regulatory data does not specify explicit storage instructions for the Advanced Dental Appliance LRK. However, since it is a dental device intended for patient use, it should be stored in a clean, dry environment, protected from contamination, and handled according to manufacturer recommendations to preserve its integrity and functionality.
How do I determine the correct size or model of the Advanced Dental Appliance LRK for a patient?
The regulatory data lists multiple FEI numbers (e.g., 3000126629, 3013548547) associated with the Advanced Dental Appliance LRK, which likely correspond to different sizes or models. To determine the correct fit for a patient, you should consult the manufacturer’s sizing guidelines or instructions, which are not detailed in the provided data but are typically included in the product documentation.