Dura-Green

Dura Green Fine HP TC4

Registry build 21.09.26
9manufacturers in China registered for this device type
94catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code EHL
Manufacturer City Province Registered as Device types
Ningbo Xinwell Medical Technology Co., Ltd. Cixi Zhejiang Contract manufacturer 12
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50
Henan Baistra Medical Devices Limited Zhengzhou Henan Manufacturer 34
Tangshan Zhengtong Exhibition Co., Ltd. Tangshan Hebei Manufacturer 34
Gavin Biotechnology Co., Ltd. Jinzhong Shanxi Manufacturer 16
Henan Lusterdent Medical Instrument Co., Ltd. Zhengzhou Henan Manufacturer 15
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Shanghai Shofu Dental Material Co., Ltd. Shanghai Shanghai Manufacturer 3

Record

Regulatory record for Dura-Green
Listed by Shofu Dental Corp., United States
FDA product code EHL
Device type Point, Abrasive
Device class Class 1
Regulation 21 CFR 872.6010
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2021-02-04

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

Catalogue Numbers

Catalogue numbers for Dura-Green
Catalogue number Size Status
0026 In distribution
0107 In distribution
0041 In distribution
0156 In distribution
042F In distribution
0082 In distribution
0040 In distribution
0021 In distribution
0110 In distribution
0048 In distribution
0095 In distribution
0045 In distribution
0046 In distribution
0152 In distribution
0052 In distribution
0101 In distribution
0037 In distribution
0012 In distribution
045F In distribution
0027 In distribution
0085 In distribution
0054 In distribution
0029 In distribution
0006 In distribution
0031 In distribution
0084 In distribution
0047 In distribution
048F In distribution
0096 In distribution
0068 In distribution
0030 In distribution
0022 In distribution
0167 In distribution
022F In distribution
0011 In distribution
0104 In distribution
0159 In distribution
0157 In distribution
0042 In distribution
030F In distribution
0158 In distribution
0016 In distribution
0010 In distribution
0053 In distribution
0062 In distribution
0098 In distribution
0025 In distribution
0066 In distribution
0028 In distribution
0032 In distribution
0092 In distribution
039F In distribution
0035 In distribution
0105 In distribution
0007 In distribution
0018 In distribution
0109 In distribution
0023 In distribution
0019 In distribution
0008 In distribution
0089 In distribution
0155 In distribution
0081 In distribution
0080 In distribution
0161 In distribution
011F In distribution
0044 In distribution
0043 In distribution
0015 In distribution
0060 In distribution
0033 In distribution
0034 In distribution
0017 In distribution
0168 In distribution
0103 In distribution
0059 In distribution
0083 In distribution
0162 In distribution
0014 In distribution
0061 In distribution
0036 In distribution
0090 In distribution
0057 In distribution
031F In distribution
0153 In distribution
0154 In distribution
0013 In distribution
0002 In distribution
0020 In distribution
0108 In distribution
0086 In distribution
0064 In distribution
0039 In distribution
0009 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Brasseler USA Peter Brasseler Holdings, LLC 313
Point, Abrasive Hager & Meisinger Gesellschaft mit beschränkter Haftung 265
Jazz Polisher SS White Burs LLC 128
Sunshine Diamonds DR. Hopf Gmbh & Co. KG 125
Horico Hopf, Ringleb & Co. Gmbh & CIE. 122
Komet Abrasive Instruments Gebr. Brasseler Gmbh & Co. KG 101
Polishers DFS-Diamon Gmbh 101
Busch®, BNA® Busch & Co. GmbH & Co. KG 85
MDT Dental Polishers M.D.T. – Micro Diamond Technologies Ltd. 81
Henry Schein Henry Schein, Inc. 75
Jota Jota AG 68
Johnson-Promident Young Innovations Inc. 37

Showing 12 of 173. All products under Point, 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