FDA.reportPublic FDA data

TORQTECH

Primary DI
04548213016617
Brand
TORQTECH
Company
J.MORITA MFG.CORP.
Model
ST-DH
Device description
Attachments for Air and Electric Motors
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103697000TORQTECHJ. Morita USA, Inc.2012-01-20EGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548213016617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548213016617045482130166174548213016617

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
693811465
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548213024698i-Dixeli-Dixel2016-09-23
04548213024704i-Dixeli-Dixel2016-09-23
04548213024711i-Dixeli-Dixel2016-09-23
04548213024728i-Dixeli-Dixel2016-09-23
04548213024735i-Dixeli-Dixel2016-09-23
04548213025176i-Dixeli-Dixel2016-09-09
04548213025183i-Dixeli-Dixel2016-09-23
04548213025282i-Dixeli-Dixel2016-09-23
04548213025299i-Dixeli-Dixel2016-09-23
04548213026760i-Dixeli-Dixel2017-02-12
04548213026777i-Dixeli-Dixel2017-02-12
04548213026784i-Dixeli-Dixel2017-02-12
04548213026791i-Dixeli-Dixel2017-02-12
04548213026807i-Dixeli-Dixel2017-02-12
04548213026814i-Dixeli-Dixel2017-02-12
04548213026821i-Dixeli-Dixel2017-02-12
04548213026838i-Dixeli-Dixel2017-02-12
04548213026845i-Dixeli-Dixel2017-02-12
04548213026852i-Dixeli-Dixel2017-02-12
04548213026944i-Dixeli-Dixel2017-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975072108SterlingBENCO DENTAL SUPPLY CO.EGS2026-08-27
00366975072115SterlingBENCO DENTAL SUPPLY CO.EGS2026-08-27
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
00304040194348Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194355Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194362Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194386Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
D66207043102302Patterson®PATTERSON DENTAL SUPPLY, INC.EGS2024-11-11
D6620704340920Patterson®PATTERSON DENTAL SUPPLY, INC.EGS2024-11-11
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002942YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002959YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002997Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003000Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003017Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003024Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29