Blue AND Green

Blue AND Green Explorer Single END #17, BG6 Handle

Registry build 21.09.26
8manufacturers in China registered for this device type
18catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EKB
Manufacturer City Province Registered as Device types
Amedcon Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Elite Dental LAB Huizhou Guangdong Manufacturer 18
Shumei Industrial (Hebei) Co., Ltd. Cangzhou Hebei Contract manufacturer 10
Guang Zhou Medclear Medical Device Service Co., Ltd. Dongguan Guangdong Contract manufacturer 9
Pengbo (Shenzhen) Medical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for Blue AND Green
Listed by Nordent Manufacturing Inc
FDA product code EKB
Device type Explorer, Operative
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2020-07-22
Record revised 2023-01-20 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Blue AND Green
Catalogue number Size Status
EXD5/BG In distribution
EXS17/BG6 In distribution
EXD5/BG6 In distribution
EXD16/BG6 In distribution
EXD2/BG In distribution
EXD3CH/BG In distribution
EXD23-6/BG In distribution
EXD11-12/BG6 In distribution
EXD3/BG In distribution
EXD23-16/BG In distribution
EXD2/BG6 In distribution
EXS17/BG16 In distribution
EXD2XL/BG In distribution
EXD16/BG In distribution
EXD11-12/BG In distribution
EXD23-16/BG6 In distribution
EXD23-6/BG6 In distribution
PUNC15-23/BG6 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Nordent Manufacturing Inc Nordent Manufacturing Inc 207
HU-Friedy HU-Friedy MFG Co., LLC 196
Hahnenkratt E. Hahnenkratt Gmbh 86
Integra® Miltex® Integra LifeSciences Production Corporation 67
Power Dental USA Power Dental U.S.A. Inc. 42
Sklar® Sklar Corporation 39
Premier Explorers Premier Dental Products Co. 35
Darby Dental Supply, LLC Darby Dental Supply, LLC 32
Brasseler USA Peter Brasseler Holdings, LLC 30
Zoll-Dental Zoll-Dental 29
National Distribution & Contracting Inc. Nordent Manufacturing Inc 28
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 26

Showing 12 of 77. All products under Explorer, 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