Manufacturer registered with FDA

QuietLab

Dubai, United Arab Emirates. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10094553Specification developer1 clearance in five years
Device types listed
1
Brands and models
1
510(k) clearances
12025–2025
Markets registered in
1United States
Establishments
1United States
2025: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What QuietLab currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Anti-Snoring DeviceLRK · Class 2Anti-snoring & jaw-repositioning devicesMaker
QuietLab Pro
2026

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names QuietLab as the applicant.

Decided510(k)DeviceDevice type
5 Dec 2025K253868QuietLab ProLRK Anti-Snoring Device

Registered establishments

EstablishmentLocationWhat it does
QuietLab LLCFDA reg. 3043364471New York, NY, United StatesSpecification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10094553). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.