FDA.reportPublic FDA data

E-CUBE

Primary DI
08809260475458
Brand
E-CUBE
Company
Saeshin Precision Co., Ltd.
Model
ACL(B)-42EM
Device description
Angle Handpiece
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111616000E-CUBESaeshin Precision Co., Ltd.2011-08-19EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809260475458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809260475458088092604754588809260475458

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688019566
Device count
1
Serial number
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
08800313230017ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230024ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230031ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230048ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230055ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230062ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237429ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237436ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237443ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237450ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237467ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237474ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237481ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237498ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237504ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
06944843655932COLTENEGuilin Woodpecker Medical Instrument Co., Ltd.EKX2026-08-18
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19