Manufacturer registered with FDA

Shanghai Dental Instrument Factory Co., Ltd.

Shanghai, China. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator9089400Manufacturer

Device types listed: 3
Brands and models: 4
510(k) clearances: 22006–2006
Markets registered in: 1United States
Establishments: 1China

510(k) clearances per year, 2000–2026

Devices listed with FDA

What Shanghai Dental Instrument Factory Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Dental Air-Powered HandpieceEFB · Class 1	Dental handpieces	Maker	CST61HIGH SPEED TURBINE	2009
Operative Dental UnitEIA · Class 1	Dental chairs & operative units	Maker	SDIF DENTAL CHAIRS WITH	2006
Dental Chair without Operative UnitNRU · Class 1	Dental chairs & operative units	Maker	SDIF DENTAL CHAIR WI	2006

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 Shanghai Dental Instrument Factory Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
15 Nov 2006	K063302	SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES	EIA Operative Dental Unit
26 Oct 2006	K063110	CST61 HIGH SPEED TURBINE HANDPIECE	EFB Dental Air-Powered Handpiece

Some of these clearances are listed with FDA today by another company: Foshan Gladent Medical Instrument Co.,Ltd. (1).

Registered establishments

Establishment	Location	What it does
SHANGHAI DENTAL INSTRUMENT FACTORY CO., LTD.FDA reg. 3006113289	SHANGHAI, China	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9089400). 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.