X-CUBE

GUDID 08809260470323

Saeshin Precision Co., Ltd.

Dental power tool system, line-powered

• Primary Device ID: 08809260470323
• NIH Device Record Key: f08fb2a4-da0c-4c67-9b12-b8e2b4696bc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-CUBE
• Version Model Number: ACL-01C
• Company DUNS: 688019566
• Company Name: Saeshin Precision Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809260470323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100192

FDA Product Code

• EGS: Handpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809260470323]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-30
• Device Publish Date: 2020-01-22

On-Brand Devices [X-CUBE]

• 08809260471054: 20:1 , non-optic X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+TRAUS CRB27XX
• 08809260471047: 32:1 , non-optic X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+TRAUS CRB26XX
• 08809260471030: '20:1, Contra Angle(Button Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEIP+ACL(B)-61
• 08809260471023: 32:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-45I
• 08809260471016: 64:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-43I
• 08809260471009: 16:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-42I
• 08809260470897: 20:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-41I
• 08809260470880: 32:1, Contra Angle(Lever Type) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-45I
• 08809260470873: 64:1, Contra Angle(Lever Type) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-43I
• 08809260470866: 16:1, Contra Angle(Lever Type) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-42I
• 08809260470859: 20:1, Contra Angle(Lever Type) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-41I
• 08809260470842: 1:1, Contra Angle(Button Type #4) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-03F
• 08809260470835: '1:1, Contra Angle(Button Type #3) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-04C
• 08809260470828: '1:1, Contra Angle(Button Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-03C
• 08809260470811: 1:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-01C
• 08809260470804: '1:1, Contra Angle(Lever Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-02C
• 08809260470798: '1:1, Contra Angle(Lever Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-01C
• 08809260470781: 1:1, Straight Angle X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ATII
• 08809260470460: Angle Handpiece
• 08809260470453: Angle Handpiece
• 08809260470446: ACL(B)-43I
• 08809260470439: Angle Handpiece
• 08809260470422: Angle Handpiece
• 08809260470415: Angle Handpiece
• 08809260470408: Angle Handpiece
• 08809260470392: Angle Handpiece
• 08809260470385: Angle Handpiece
• 08809260470378: Angle Handpiece
• 08809260470361: Angle Handpiece
• 08809260470354: Angle Handpiece
• 08809260470347: Angle Handpiece
• 08809260470330: Angle Handpiece
• 08809260470323: ACL-01C
• 08809260470316: Angle Handpiece
• 08809260470309: Implant Motor
• 08809260470293: Foot Controller
• 08809260470286: Control Box
• 08809260470200: Angle Handpiece 92.7(L) x 20.0(D)