Health-Tec/DHP Amalgam Carriers

Health-Tec/DHP Amalgam Carriers Regular/Jumbo Double End Stainless Steel Tips

Registry build 21.09.26
6manufacturers in China registered for this device type
6catalogue numbers in this listing

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 Health-Tec/DHP Amalgam Carriers
Listed by Dental Health Products Inc
FDA product code EKI
Device type Carrier, Amalgam, Operative
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2022-11-09

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Health-Tec/DHP Amalgam Carriers
Catalogue number Size Status
700-10003 In distribution
700-10004 In distribution
700-10007 In distribution
700-10002 In distribution
700-10008 In distribution
700-10001 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
Osung MND Osung MND Co., Ltd. 5
PDT, Inc. PDT, Inc. 4

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