iCTmotor WL-1
GUDID 08809460309843
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.
Dentium Co., Ltd
Dental laboratory drilling system motor| Primary Device ID | 08809460309843 |
| NIH Device Record Key | f7af7606-8788-48e5-8bbc-37290f28d14b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iCTmotor |
| Version Model Number | WL-1 |
| Catalog Number | WL-1 |
| Company DUNS | 695504638 |
| Company Name | Dentium Co., Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com | |
| Phone | +821064769603 |
| yrna@dentium.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809460309843 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193341
FDA Product Code
| EBW | Controller, Foot, Handpiece And Cord |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-21 |
| Device Publish Date | 2020-09-11 |
Devices Manufactured by Dentium Co., Ltd
| 08809772430563 - bright CT | 2024-01-03 This product is a dental computed tomography device designed to obtain images of the patient's teeth, nasal cavity, and jaw join |
| 08809772430570 - bright CT | 2024-01-03 This product is a dental computed tomography device designed to obtain images of the patient's teeth, nasal cavity, and jaw join |
| 08809772430587 - bright CT | 2024-01-03 |
| 08809772430594 - bright CT | 2024-01-03 This product is a dental computed tomography device designed to obtain images of the patient's teeth, nasal cavity, and jaw join |
| 08809772430600 - bright CT | 2024-01-03 This product is a dental computed tomography device designed to obtain images of the patient's teeth, nasal cavity, and jaw join |
| 08809772430617 - bright CT | 2024-01-03 This product is a dental computed tomography device designed to obtain images of the patient's teeth, nasal cavity, and jaw join |
| 08809460309836 - bright MCT | 2021-04-30 |
| 08809544906340 - rainbow CT | 2021-04-30 |
Trademark Results [iCTmotor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICTMOTOR 97271905 not registered Live/Pending |
Dentium Corporation 2022-02-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.