Ki-20

The Ki-20 is an electrically driven dental handpiece system for dental procedures. Its uses include endodontic surgery such as drilling into the tooth canal and general dentistry such as…

Registry build 21.09.26

The Ki-20 is an electrically driven dental handpiece system for dental procedures. Its uses include endodontic surgery such as drilling into the tooth canal and general dentistry such as removing carious material from dentin. The system includes a motor, handpieces, a control box and a foot switch.

The control box and foot switch control the handpiece speed and direction. An E-type motor drives the handpiece, while a pump and irrigation tubing supply cooling water during the procedure. The controls also allow torque settings and stored operating programs.

Motor Settings

The motor speed range is 600 to 40,000 rpm and its torque setting range is 5 to 65 Ncm. The system supports forward and reverse rotation and selection of gear ratios for compatible E-type handpieces.

4manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangxi (2), Guangdong (2).

Chinese manufacturers registered for FDA product code EBW
Manufacturer City Province Registered as Device types
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Guangxi Ehall Medical Technology Co., Ltd. Nanning Guangxi Manufacturer 17
Foshan Cicada Dental Instrument Co., Ltd. Foshan Guangdong Manufacturer 15

Record

Regulatory record for Ki-20
Listed by Saeyang Microtech Co., Ltd., South Korea
FDA product code EBW
Device type Controller, Foot, Handpiece And Cord
Device class Class 1
Regulation 21 CFR 872.4200
510(k) K141482
Record published 2020-09-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Ki-20
Catalogue number Size Status
Ki-20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
A-dec A-dec, Inc. 43
X-Cube Saeshin Precision Co., Ltd. 22
Maxso Beyes Dental Canada, Inc. 20
NLZ Nakanishi Inc. 16
Surgic Pro Nakanishi Inc. 15
Brasseler USA Peter Brasseler Holdings, LLC 13
DTE Guilin Woodpecker Medical Instrument Co., Ltd. 11
woodpecker Guilin Woodpecker Medical Instrument Co., Ltd. 10
NL400 Nakanishi Inc. 9
NLX Nakanishi Inc. 9
Surgic XT Plus Nakanishi Inc. 6
Axiom® Etablissements Anthogyr 6

Showing 12 of 256. All products under Controller, Foot, Handpiece And Cord

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K141482 2015-04-24
K123608 2013-08-16

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