Kohdent

Retraction cord packer, round, large toothed version, with TRINOVO handle

Registry build 21.09.26
29manufacturers in China registered for this device type
13catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Jiangsu (6), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EJB
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Coda Resources Ltd., Heze China Heze Shandong Contract manufacturer 9
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
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52

Showing 12 of 29. All 29 manufacturers in China registered for Handle, Instrument, Dental

Record

Regulatory record for Kohdent
Listed by Kohler Medizintechnik GmbH, Germany
FDA product code EJB
Device type Handle, Instrument, Dental
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Private-label distributor, Manufacturer, Exporter
Premarket notification Exempt
Record published 2021-08-30
Record revised 2025-03-25 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Kohdent
Catalogue number Size Status
4114 In distribution
7457 In distribution
4249 In distribution
7640 In distribution
5070 In distribution
9218-DE In distribution
7470 In distribution
5071 In distribution
6870 In distribution
4354 In distribution
5974 In distribution
9218 In distribution
4352 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 121
Brasseler USA Peter Brasseler Holdings, LLC 89
Premium Plus Premium Plus International Limited 83
Surgical Kit Shinhung MST Co., Ltd. 78
Hahnenkratt E. Hahnenkratt Gmbh 59
Bioclear Diamond Wedge Bioclear Matrix Systems, LLC 50
Hygitech Hygitech 47
Plasdent Plasdent Corp. 37
Stoma® Storz AM Mark Gmbh 34
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 34
LMDental LM-Dental 33
Henry Schein Henry Schein, Inc. 32

Showing 12 of 221. All products under Handle, Instrument, Dental

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