FDA.reportPublic FDA data

X-CUBE

Primary DI
08809260470453
Brand
X-CUBE
Company
Saeshin Precision Co., Ltd.
Model
ACL(B)-45I
Device description
Angle Handpiece
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
EFAHandpiece, Belt And/Or Gear Driven, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFAHandpiece, Belt And/Or Gear Driven, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092412000STRONG IMPLANT HANDPIECESSaeshin Precision Co., Ltd.2009-09-03EFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809260470453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809260470453088092604704538809260470453

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
04548213060153STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213060160STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213060177STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213057320TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057337TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057344TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057368TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057375TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
03663394482325HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-08-20
D950116461PastelLARES RESEARCHEFA2025-05-02
03663394170871IMPULSIONETABLISSEMENTS ANTHOGYREFA2025-02-13
00304040189641MaximaHENRY SCHEIN, INC.EFA2025-01-14
EKAV101402800MASTERmatic LUX M45 LKaVo Dental GmbHEFA2024-02-01
03663394170796AXIOM®ETABLISSEMENTS ANTHOGYREFA2023-12-28
03663394169929AXIOM®ETABLISSEMENTS ANTHOGYREFA2023-12-27
03663394169936AXIOM®ETABLISSEMENTS ANTHOGYREFA2023-12-27
04548213745043Midwest 45 FBE NFOJ.MORITA MFG.CORP.EFA2023-08-18
04548213745241Midwest 45 K-Style NFOJ.MORITA MFG.CORP.EFA2023-08-18
04548213008476N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008483N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008506N/AJ.MORITA MFG.CORP.EFA2022-12-12
04548213008513TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008537TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008544TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008551TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008568TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008575TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008582TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12
04548213008599TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2022-12-12