SM3

S200EL Contra angle only - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental…

Registry build 21.09.26

S200EL Contra angle only – The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

1manufacturer
3catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code KMW
Manufacturer City Province Registered as Device types
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19

Record

Regulatory record for SM3
Listed by Osstem Implant Co., Ltd._Gasan Branch
FDA product code KMW
Device type Handpiece, Rotary Bone Cutting
Device class Class 2
Regulation 21 CFR 872.4120
Record published 2019-04-25

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for SM3
Catalogue number Size Status
SM3 120V OPT In distribution
S200EL In distribution
SL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OsteoMed Osteomed 297
Ti-Max X Nakanishi Inc. 19
Micro Surgery Handpiece Nakanishi Inc. 4
Turning Handle W&H Dentalwerk Bürmoos GmbH 4
SGM-ER32i Nakanishi Inc. 3
Ti-Max Nakanishi Inc. 3
SGQ-H Nakanishi Inc. 3
Sgms-I Nakanishi Inc. 2
S-Max M Nakanishi Inc. 2
SGM-I Nakanishi Inc. 2
SGM-ER16i Nakanishi Inc. 2
SGS-ES Nakanishi Inc. 2

Showing 12 of 93. All products under Handpiece, Rotary Bone Cutting

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