Kohdent

Guttapercha removal instrument ELES 18/30 mm, diamond coated, TRINOVO PEEK black

Registry build 21.09.26
34manufacturers in China registered for this device type
19catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (8), Jiangsu (6), Hebei (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EIX
Manufacturer City Province Registered as Device types
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Amedcon Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shandong Zhushi Pharmaceutical Group Co., Ltd. Heze Shandong Contract manufacturer 65
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52

Showing 12 of 34. All 34 manufacturers in China registered for Probe, Periodontic

Record

Regulatory record for Kohdent
Listed by Kohler Medizintechnik GmbH, Germany
FDA product code EIX
Device type Probe, Periodontic
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 3)

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
9206 In distribution
8446 In distribution
8425 In distribution
8426 In distribution
7537 In distribution
7535 In distribution
9208 In distribution
8423 In distribution
9207 In distribution
7539 In distribution
5156 In distribution
8422 In distribution
7536 In distribution
7538 In distribution
9205 In distribution
5157 In distribution
8447 In distribution
8462 In distribution
8424 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 354
Surgical Direct Surgical Direct, Inc. 195
Nordent Manufacturing Inc Nordent Manufacturing Inc 143
American Eagle Instruments American Eagle Instruments 127
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 74
Integra® Miltex® Integra LifeSciences Production Corporation 61
Power Dental USA Power Dental U.S.A. Inc. 57
Osung MND Osung MND Co., Ltd. 52
Premier Probes Premier Dental Products Co. 52
Pomee Pomee Corporation 51
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 41
Henry Schein Henry Schein, Inc. 38

Showing 12 of 64. All products under Probe, Periodontic

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