E-CUBE

GUDID 08809260470507

Angle Handpiece

Saeshin Precision Co., Ltd.

Dental power tool system, line-powered

• Primary Device ID: 08809260470507
• NIH Device Record Key: f1afc37b-7524-4d23-ac60-c2c6e9913f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-CUBE
• Version Model Number: ACL(B)-42EP
• 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	08809260470507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111616

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[08809260470507]

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 [E-CUBE]

• 08809260470910: 20:1, EP Type E-CUBE(C/B)+CUBE-EP+ACL(B)-42EP
• 08809260470903: 20:1, EM Type E-CUBE(C/B)+CUBE-EM+ACL(B)-42EM
• 08809260470514: Angle Handpiece
• 08809260470507: Angle Handpiece
• 08809260470491: Implant Motor
• 08809260470484: Implant Motor
• 08809260470477: Control Box