Manufacturer registered with FDA

Shenzhen Kesite Digital Technology Co., Ltd.

Shenzhen, China. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10093764Manufacturer
Device types listed
1
Brands and models
2
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1China

Devices listed with FDA

What Shenzhen Kesite Digital Technology Co., Ltd. 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
PoZent Tongue Stabilizing Device Mouthpiece; IFGZQU Tongue Stabilizing Device MouthpieceUpverxi Snore Mouthguard; SnoreBandit Anti-Snoring Appliance
2025

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

Also lists devices cleared under other names

Shenzhen Kesite Digital Technology Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Innovative Health Technologies (NZ) Limited (1), Snorebandit, LLC (1).

Decided510(k)DeviceApplicantDevice type
18 Sep 2023K231663The AVEOtsd (Tongue Stabilizing Device) MouthpieceInnovative Health Technologies (NZ) LimitedLRK Anti-Snoring Device
1 Jul 2021K210910Snore BanditSnorebandit, LLCLRK Anti-Snoring Device

Registered establishments

EstablishmentLocationWhat it does
SHENZHEN KESITE DIGITAL TECHNOLOGY CO., LTD.FDA reg. 3039443708Shenzhen Guangdong, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10093764). 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.