Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013538161

FEI Number

3013538161

Entity Name

SHANGHAI FANTA DENTAL MATERIALS CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Room502, Building 1, #599 Shuang Dan Rd, Jiading Dist, Shanghai 201801, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shanghai Fanta Dental Materials Co., Ltd. (Owner Number: 10054349)

Owner / Operator Contact Address

Room1503, #7 Pu Bei Rd, Xuhui Dist, Shanghai, CN-SH 200235, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MAGNEE-Endo File Organizer DOWN PACK GUTTA PERCHA BAR C-HANDLE-Endo File Holder Stainless Steel K FILE; C-FLEX FILE AF F ONE AF CL Stainless Steel H FILE, NiTi Rotary File AF MAX3 AF MAX1 BLUE AF BLUE R3 AF ROTARY AF MAX2 BLUE C-PATH BLUE V-TAPER ROTARY V-TAPER HAND V-TAPER GOLD AF BLUE ROTARY AF BABY AF MAX1 C-PATH AF MAX3 BLUE AF F ONE BLUE AF BLUE S ONE AF RETREATMENT V-TAPER BLUE AF MAX2 Harmony Surgical Microscope Irrigation Needle 3D Tooth

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-02-14
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2022-02-14
EKM	Gutta-Percha	Dental	Class 1	872.3850	2017-03-09
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2022-02-14
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2017-03-09
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2017-03-09
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2017-03-09
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2023-05-04
DZM	Needle, Dental	Dental	Class 1	872.4730	2022-02-14
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2022-02-14
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2017-03-09

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Shanghai Fanta Dental Materials 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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013538161. Last updated year: 2026. Please use registration number 3013538161 when referencing this establishment in official correspondence.