FDA.reportPublic FDA data

iCTmotor

Primary DI
08809460309843
Brand
iCTmotor
Company
Dentium Co., Ltd
Model
WL-1
Catalog number
WL-1
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.
Published
2020-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBWController, Foot, Handpiece And Cord

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193341000iCTmotor (WL-1)Dentium Co., Ltd.2020-09-04EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809460309843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809460309843088094603098438809460309843

GMDN Terms#

Term, Definition table
TermDefinition
Dental laboratory drilling system motorA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+821064769603yrna@dentium.com

Regulatory Flags#

DUNS number
695504638
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809772430563bright CTICT-R02-1T2023-12-26
08809772430570bright CTICT-R02-1TC2023-12-26
08809772430587bright CTICT-R02-2T2023-12-26
08809772430594bright CTICT-R02-2TC2023-12-26
08809772430600bright CTICT-R02-2TS2023-12-26
08809772430617bright CTICT-R02-2TSC2023-12-26
08809460309836bright MCTICT-R01-M2021-04-22
08809544906340rainbow CTICT-R012021-04-22
08809544906357rainbow CTICT-R01-L2021-04-22
08809460309850Intra Oral SensorIOX1IOX12020-08-06
08809460309867Intra Oral SensorIOX2IOX22020-08-06

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Primary DI, Brand, Company table
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08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
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10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19
E27668312130Midwest Motor Control ModuleSIRONA Dental Systems GmbHEBW2026-02-17
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00810126043153SM7 US ( Complete Set )HIOSSEN, INC.EBW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.EBW2026-01-09
08404535021684ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
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04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
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