LMDental

LM-TwistOut S4 DTS, Extraction

Registry build 21.09.26
6manufacturers in China registered for this device type
40catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code EMJ
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
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
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17

Record

Regulatory record for LMDental
Listed by LM-Dental
FDA product code EMJ
Device type Elevator, Surgical, Dental
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2020-08-31
Record revised 2022-04-15 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for LMDental
Catalogue number Size Status
814240 In distribution
812450 In distribution
812440T In distribution
814240T In distribution
814230 In distribution
812640T In distribution
814430 In distribution
814230T In distribution
812240T In distribution
812210T In distribution
812650T In distribution
812830T In distribution
812440 In distribution
814440T In distribution
812830 In distribution
812850T In distribution
812430 In distribution
814450T In distribution
814250T In distribution
812640 In distribution
814440 In distribution
812650 In distribution
812220 In distribution
812230 In distribution
812630 In distribution
814250 In distribution
812850 In distribution
812840T In distribution
812840 In distribution
812230T In distribution
812240 In distribution
812220T In distribution
812210 In distribution
812430T In distribution
812250T In distribution
814450 In distribution
814430T In distribution
812250 In distribution
812450T In distribution
812630T 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 465
Nordent Manufacturing Inc Nordent Manufacturing Inc 264
Power Dental USA Power Dental U.S.A. Inc. 247
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 233
Elevator KLS-Martin L.P. 231
Kohdent Kohler Medizintechnik GmbH 206
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 153
Stoma® Storz AM Mark Gmbh 150
Reicodent Devemed Gmbh 142
Sklar Sklar Corporation 130
Osung MND Osung MND Co., Ltd. 126
Karl Schumacher Karl Schumacher Dental, LLC 121

Showing 12 of 743. All products under Elevator, Surgical, 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