Ezr™

Disc Polisher, Medium Grit, Green

Registry build 21.09.26
4manufacturers in China registered for this device type
3catalogue 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 eZr™
Listed by Garrison Dental Solutions, L.L.C.
FDA product code EHJ
Device type Disk, Abrasive
Device class Class 1
Regulation 21 CFR 872.6010
Premarket notification Exempt
Record published 2020-04-24
Record revised 2020-07-07 (version 2)

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
Packaging Fpzm030-x of 5, fpzm030 of 5, fpzc030-x of 5, fpzc030 of 5, fpzf030-x of 5, fpzf030 of 5

Catalogue Numbers

Catalogue numbers for eZr™
Catalogue number Size Status
FPZM030-1 In distribution
FPZC030-1 In distribution
FPZF030-1 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
Polishers DFS-Diamon Gmbh 24
OptraGloss Ivoclar Vivadent Aktiengesellschaft 23
Astropol Ivoclar Vivadent Aktiengesellschaft 22
Super-Snap Shofu Dental Corp. 19
Sandpaper Discs TDV Dental Ltda 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