Kohdent

Tongue depressor WIEDER small -13cm- 38x31 mm

Registry build 21.09.26
10manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (3), Jiangsu (3), Shandong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KBL
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Shanghai NEO-Medical Import & Export Co., Ltd. Shanghai Shanghai Exporter 59
Nanning Tecbod Biological Technology Co., Ltd. Nanning Guangxi Contract manufacturer 51
Little Doctor Electronic(Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 17
Shanghai FLY Medical Devices Co., Ltd. Minhang District Shanghai Manufacturer 15

Record

Regulatory record for Kohdent
Listed by Kohler Medizintechnik GmbH, Germany
FDA product code KBL
Device type Depressor, Metal Tongue, Surgical
Device class Class 1
Regulation 21 CFR 874.4420
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
4819 In distribution
7251 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar Sklar Corporation 58
MicroFrance® Integra Microfrance SAS 18
Davis-Boyle tongue depressor Spiggle & Theis Medizintechnik Gmbh 14
Russel-Davis tongue depressor Spiggle & Theis Medizintechnik Gmbh 11
Aesculap Aesculap AG 10
Millennium Avalign Technologies, Inc. 9
Ambler Surgical Ambler Surgical, LLC 8
MSI Precision Specialty Instruments MED Saver, Inc. 7
BR Surgical, LLC BR Surgical LLC 6
Integra® Miltex® Integra LifeSciences Production Corporation 6
Novo Surgical Inc. Novo Surgical, Inc. 5
Tongue depressor, Wuerzburg type Spiggle & Theis Medizintechnik Gmbh 5

Showing 12 of 48. All products under Depressor, Metal Tongue, Surgical

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