AccessGUDID - DEVICE: iCTmotor (08809460309843)

GUDID

Device Identifier (DI) Information

Brand Name: iCTmotor
Version or Model: WL-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WL-1
Company Name: Dentium Co., Ltd

Primary DI Number: 08809460309843
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695504638 *Terms of Use

Device Description: As an electric drive motor used in the implant surgery by a dental specialist, the iCTmotor is an instrument tool used in cutting pubic bone, setting an implant or abutment when it combines to a hand-piece in which includes a medical drill, and also has the functions necessary to combine with other devices. The motor was designed as being able to control rotational speed (RPM) and torque, and to select variable options and/or cooling water-supply according to surgery steps. The motor has various ratios in the final value of rotational speed and torque, according to a mechanical reduction gear ratio.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34699	Dental laboratory drilling system motor	A mains electricity (AC-powered) engine (motor) used in a dental laboratory in conjunction with a flexible drive system (e.g., a Bowden cable) to provide the rotational power for a dental laboratory handpiece. It is typically combined with different speed controllers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBW	Controller, Foot, Handpiece And Cord

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193341	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7af7606-8788-48e5-8bbc-37290f28d14b
Public Version Date: September 21, 2020
Public Version Number: 1
DI Record Publish Date: September 11, 2020