FDA.reportPublic FDA data

X-CUBE

Primary DI
08809260470842
Brand
X-CUBE
Company
Saeshin Precision Co., Ltd.
Model
X-CUBE #7
Device description
1:1, Contra Angle(Button Type #4)X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-03F
Published
2020-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K092758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092758000X-CUBESaeshin Precision Co., Ltd.2009-09-21EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809260470842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809260470842088092604708428809260470842

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
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
00366975069252SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069276Sterling Surgical Motor Main ConsoleBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069283SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069290SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069306SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008444A-decA-DEC, INC.EBW2026-02-19
10194665008475A-decA-DEC, INC.EBW2026-02-19
10194665008482A-decA-DEC, INC.EBW2026-02-19
10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19