Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016170492

FEI Number

3016170492

Entity Name

SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.

City/State/Country

Shanghai, CN

Establishment Address

Suite 2063, 2ND Floor, Building 2, No.399, Fengyun road, Fengxian district, Shanghai 201400 China, Shanghai 201400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Alwings Medical Instrument Co.,Ltd. (Owner Number: 10061662)

Owner / Operator Contact Address

Suite 2063, 2ND Floor, Building 2, No.399, Fengyun road, Fengxian district, Shanghai 201400 China, Shanghai, CN-SH 201400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

X-ray Film Holder X-ray Film Clip Plastic Holder Barrier Envelope Plastic Dispenser Impression Tray Bite Registration Tray Dental Tray Mixing Bowl Bib Clip Dental Wedge Micro Applicator Tips Dappen Dishes Spatulas Dental Forcep Articulating Paper Impression Syringe Irrigation Syringe Dental Syringe Gauze Swab Gauze Sponge Non-woven Gauze Surgical Gown Lead Apron Face Mask Protective Glasses Face Shield Air/Water Syringe Tip Bouffant Cap Surgical Cap Dental Cutter Dental Drill Dental Polishing Instrument Kit Dental Polishing Disc Dental Bur X-ray Film Intra-oral Digital Imaging Plate Dental Examination Kit Dental Implant Kit Dental Floss Denture Box Retainer Box Shoe Cover Evacuator Tip Dental Bib Absorbent Paper Point Surigcal Aspirator Tip Saliva Ejector Dental Covers Dental Barrier Sleeves Dental Sheath Barrier Film Dental Headrest Covers Mouth Mirror Prophy Angles Paper Cup Prophy Cup Plastic Cup Prophy Brush Gutta Percha Point Dental Probe Dental Examination Kit Dental Tweezer Endo Reamer Endo File Fiber Post Endo Drill Mixing Gun Mouth Opener Cheek Retractor, Mouth Support Mixing Tip Amalgam Carrier Mixing Well Dental Paper Tray Sharp Container Dental Plastic Tray Instrument Code Ring Protective Glass Safety Glass Eye Shield Evacuator Tip Dental Irrigation Kit Evacuator Tip Saliva Ejector Surigcal Aspirator Tip Cotton Ball Cotton Pallet Cotton Roll Cotton Applicator Tips Surgical Blade Scalpel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2019-11-11
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2019-11-11
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-11-11
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2019-11-11
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2019-11-11
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2019-11-11
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-11-11
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2019-11-11
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2019-11-11
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2019-11-11
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2024-03-01
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2019-11-11
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-11-11
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2019-11-11
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2019-11-11
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2019-11-11
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2019-11-11
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2019-11-11
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2019-11-11
EKM	Gutta-Percha	Dental	Class 1	872.3850	2019-11-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-11-11
ELR	Post, Root Canal	Dental	Class 1	872.3810	2019-11-11
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2019-11-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-12-16
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2019-11-11
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2019-11-11
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2019-11-11
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2019-11-11
EFN	Cotton, Roll	Dental	Class 1	872.6050	2019-11-11
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2019-11-11

Official Correspondent

Liu Weiping

US Agent Details

James St. Wu Business: Humiss inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Shanghai Alwings Medical Instrument 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

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3015509619	DURR DENTAL SE	Bietigheim-Bissingen Baden-Wurttemberg, DE
3011944170	ZAPALIGN INC.	Anyang-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016170492. Last updated year: 2026. Please use registration number 3016170492 when referencing this establishment in official correspondence.