FDA.reportPublic FDA data

E-CUBE

Primary DI
08809260470910
Brand
E-CUBE
Company
Saeshin Precision Co., Ltd.
Model
E-CUBE #1
Device description
20:1, EP TypeE-CUBE(C/B)+E-CUBE FOOT+CUBE-EP+ACL(B)-42EP
Published
2020-01-22
Public version status
Update
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
08809260470910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809260470910088092604709108809260470910

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
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
00858466005257ENDOMAXDENTAMERICA, INC.EKX2026-04-22
00858466005240ENDOMAXDENTAMERICA, INC.EKX2026-04-21
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
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
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
10194665008550A-decA-DEC, INC.EKX2026-02-19
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
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D100B00XSGOAC0007X-Smart® Go Protective silicone sleeveFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100BSPXSGOAC0005X-Smart® Go Power bankFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
09010522002674MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518334InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
09010522002575Osstell SmartPeg Type 113Osstell ABEKX2025-03-27
09010522002599Osstell SmartPeg Type 114Osstell ABEKX2025-03-27
09010522002612Osstell SmartPeg Type 115Osstell ABEKX2025-03-27
09010522002483SmartPeg Type 117Osstell ABEKX2024-05-15