Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008352964

FEI Number

3008352964

Entity Name

SHANGHAI DOCHEM INDUSTRIES CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

Suite E2014, 2nd Floor, No.3558, Zhenbei Road, Putuo District,, SHANGHAI 200062, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Dochem Industries Co., Ltd. (Owner Number: 10032110)

Owner / Operator Contact Address

Suite E2014, 2nd Floor, No.3558, Zhenbei Road, Putuo District,, Shanghai, CN-SH 200062, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Brackets Plastic Endo Ruler Aluminum Endo Ruler Dental bib/apron Biodegradable Dental Bib Bouffant Cap, shoe cover Single use dental probe; Spatula Niti/Stainless Steel Endo File Impression mixing tips intra-oral tips Prophy Cup Prophy Brush Cotton Roll X-ray film holder, film-holder Bendable brush applicator Valustick Sticky Applicator composite brush and replaceable tip Micro Applicator Tattoo Wipes Examination Table Roll Curved Utility Syringe disposable air/water syringe tip Air/water Syringe tip Disposable Pre-bent Needle tips Dental loupes/magnifier Dental headlight Disposable air/water syringe tip Ligature Ties Power Chains Arch Wires Clips for Bibs Disposable safety glasses, face shield Bed Sheet Tattoo Drape Sheet Disposable Underpad Wrap Baby Change Mat evacuator tips Saliva ejector Surgical aspirator tips Tip Inserts/ Jet Inserts/ Surge Inserts chair cover barrier film plastic instrument sleeves plastic device sleeves headrest cover plastic dappen baby tooth box Disposable Intraoral Camera Sheath Infection Control Barrier Denture Box X-Ray Sensor Cover Tattoo Needle Hairdressing Cape 3-way syringe Isolator Cotton Rolls Holder Adapter Autoclavable HVE Suction Tubes Drape with hole CSR Wrap Disposable Mouth Mirror Toilet Seat Cover Medical Bandage Tapes Cohesive Bandage Rubber Mixing Blow Disposable dental impression syringe Cotton Filled Exodontia Sponges all-gauze sponges Non-woven Swab (Sponge) Cotton Wipe Endo Foam Paper Mixing Pad Impression tray Tray Cover Disposable impression bite registration tray Impression Gun Isolation gowns, Lab gowns

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2022-03-16
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2023-12-18
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2010-04-09
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-04-09
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2010-04-09
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2010-04-09
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2010-04-09
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2023-12-18
EFN	Cotton, Roll	Dental	Class 1	872.6050	2010-04-09
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2010-04-09
KXR	Applicator, Resin	Dental	Class 1	872.3140	2010-04-09
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-11-21
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2023-11-21
DZM	Needle, Dental	Dental	Class 1	872.4730	2010-04-09
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2022-03-16
HBR	Rack, Clip	Neurology	Class 1	882.4215	2023-12-18
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2010-04-09
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-11-21
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2010-04-09
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2010-04-09
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-11-21
IWO	Apron, Protective	Radiology	Class 1	892.6500	2023-11-21
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2010-04-09
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2023-12-18
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2023-11-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-05-04
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2010-04-09
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2023-11-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-11-21
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-12-18
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2010-04-09
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2010-04-09
FNW	Pad, Kelly	General, Plastic Surgery	Class 2	878.4370	2022-11-25
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2010-04-09
JRO	Blender/Mixer	Clinical Chemistry	Class 1	862.2050	2023-12-18
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2010-04-09

Official Correspondent

Jeffery Fei

US Agent Details

Creekon Yang Business: SPICA MEDTECH CORP Email: fda.agent@spicagloble.com Phone: (720) 6176666

Related Public Records

Same Entity

Shanghai Dochem Industries Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008352964. Last updated year: 2026. Please use registration number 3008352964 when referencing this establishment in official correspondence.