Manufacturer registered with FDA

Guangdong Yadeng Medical Apparatus Co.,Ltd

Foshan, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10095380Manufacturer1 clearance in five years
Device types listed
2
Brands and models
2
510(k) clearances
12025–2025
Markets registered in
1United States
Establishments
1China
2025: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Guangdong Yadeng Medical Apparatus Co.,Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Operative Dental UnitEIA · Class 1Dental chairs & operative unitsMaker
Integral Dental Unit Model: YD-A4, AD-S1, AD-S3, AD-S6
2026
Dental Chair with Operative UnitKLC · Class 1Dental chairs & operative unitsMaker
Integral Dental Unit Model: YD-A4, AD-S1, AD-S3, AD-S6
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 Guangdong Yadeng Medical Apparatus Co.,Ltd as the applicant.

Decided510(k)DeviceDevice type
27 Jun 2025K243130Integral Dental UnitEIA Operative Dental Unit

Registered establishments

EstablishmentLocationWhat it does
GUANGDONG YADENG MEDICAL APPARATUS CO.,LTDFDA reg. 3043582432Foshan Guangdong, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10095380). 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.