FDA.reportPublic FDA data

X-CUBE

Primary DI
08809260470200
Brand
X-CUBE
Company
Saeshin Precision Co., Ltd.
Model
TRAUS CRB26XX
Catalog number
TRAUS CRB26XX
Device description
Angle Handpiece92.7(L) x 20.0(D)
Published
2020-01-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKYHandpiece, Water-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKYHandpiece, Water-PoweredDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123695000TRAUS SIP10Saeshin Precision Co., Ltd.2012-12-18EKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809260470200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809260470200088092604702008809260470200

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system, line-poweredAn assembly of devices designed to both bore/excavate and saw bones, teeth, and tough tissues during a dental/maxillofacial surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the cutting instruments (e.g., drills, saw blades, burs, polishing disks). The system is electrically-powered from the mains (e.g., 230 or 115 volt) and supplies the handpiece/motor with low-voltage electricity (e.g., 24 volt) through the control unit. The system may operate through a dental delivery system or be freestanding and independent. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688019566
Device count
1
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809260475656Henry ScheinMaxima Elite i2026-05-21
08809260475663Henry ScheinMaxima Elite iL2026-05-21
08809260475687Oral irrigation unitDB-0012026-05-21
08809260475694Oral irrigation unitDB-0052026-05-21
08809260473430TRAUSMBP20SX2026-05-20
08809260475649TRAUS SSG40SSG40 #32026-05-19
08809260472037TRAUSSC-012026-05-07
08809260472853TRAUSCSH20NN2026-05-07
08809260472860TRAUSCSH30NN2026-05-07
08809260472877TRAUSCSH11XX2026-05-07
08809260472884TRAUSTSH11XX2026-05-07
08809260472891TRAUSTC002026-05-07
08809260472907TRAUSTC102026-05-07
08809260472914TRAUSTC202026-05-07
08809260472921TRAUSTC352026-05-07
08809260471924TRAUSSP-028i2026-05-06
08809260471931TRAUSSP-024i2026-05-06
08809260471948TRAUSSP-0162026-05-06
08809260471955TRAUSSP-SAW2026-05-06
08809260471962TRAUSSP-SAW L2026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260475656Henry ScheinSaeshin Precision Co., Ltd.EKY2026-05-21
08809260475663Henry ScheinSaeshin Precision Co., Ltd.EKY2026-05-21
08809260470156TRAUSSaeshin Precision Co., Ltd.EKY2026-04-01
08809260470170TRAUSSaeshin Precision Co., Ltd.EKY2026-04-01
08809260470187TRAUSSaeshin Precision Co., Ltd.EKY2026-04-01
08809260470163TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
08809260470705TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
08809260470712TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
08809260470729TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
08809260470736TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
00304040110850Henry ScheinHENRY SCHEIN, INC.EKY2019-06-05
00304040110867Henry ScheinHENRY SCHEIN, INC.EKY2019-06-05