MAP System, Stainless Steel Well

Stainless Steel Well

Registry build 21.09.26
6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (2), Shandong (2), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EKI
Manufacturer City Province Registered as Device types
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54

Record

Regulatory record for MAP System, Stainless Steel Well
Listed by Produits dentaires S.A.
FDA product code EKI
Device type Carrier, Amalgam, Operative
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2022-06-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for MAP System, Stainless Steel Well
Catalogue number Size Status
20250 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 23
Integra® Miltex® Integra LifeSciences Production Corporation 22
Darby Dental Supply, LLC Darby Dental Supply, LLC 18
Henry Schein Henry Schein, Inc. 17
Zoll-Dental Zoll-Dental 14
Nordent Manufacturing Inc Nordent Manufacturing Inc 13
Buffalo Dental Mfg Buffalo Dental Manufacturing Co., Inc. 13
Power Dental USA Power Dental U.S.A. Inc. 9
J & J Instruments J & J Instruments, LLC 9
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 6
Health-Tec/DHP Amalgam Carriers Dental Health Products Inc 6
Osung MND Osung MND Co., Ltd. 5

Showing 12 of 64. All products under Carrier, Amalgam, Operative

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer