Polishers

DIAFIX ORAL 9 mm x 3 mm, pu: 12 pcs;mounted

Registry build 21.09.26
4manufacturers in China registered for this device type
24catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (3), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EHJ
Manufacturer City Province Registered as Device types
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Shanghai Dochem Industries Co., Ltd. Shanghai Shanghai Manufacturer 45
Shanghai Shofu Dental Material Co., Ltd. Shanghai Shanghai Manufacturer 3

Record

Regulatory record for Polishers
Listed by DFS-Diamon Gmbh, Germany
FDA product code EHJ
Device type Disk, Abrasive
Device class Class 1
Regulation 21 CFR 872.6010
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2020-11-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Polishers
Catalogue number Size Per pack Status
800630 In distribution
800836 6 In distribution
82099 6 In distribution
80041 In distribution
80099 12 In distribution
800579 6 In distribution
80093D In distribution
81092D In distribution
80092-12 12 In distribution
81099 12 In distribution
800830 In distribution
80122 In distribution
80092 In distribution
800660 In distribution
800997 50 In distribution
81092 In distribution
800666 6 In distribution
800690 In distribution
800779 6 In distribution
800636 6 In distribution
800696 6 In distribution
800770 In distribution
810997 50 In distribution
800570 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MDT Diamond Coated Dental Discs M.D.T. – Micro Diamond Technologies Ltd. 684
Disk, Abrasive Dentaurum GmbH & Co. KG 36
Praxis TDV Dental Ltda 32
3M™ Sof-Lex™ 3M Company 27
Mounted Stones American Tooth Industries 26
Sunshine Diamonds DR. Hopf Gmbh & Co. KG 25
Horico Hopf, Ringleb & Co. Gmbh & CIE. 24
OptraGloss Ivoclar Vivadent Aktiengesellschaft 23
Astropol Ivoclar Vivadent Aktiengesellschaft 22
Super-Snap Shofu Dental Corp. 19
Sandpaper Discs TDV Dental Ltda 15
OptiDisc Kerr Corporation 15

Showing 12 of 190. All products under Disk, Abrasive

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