SDI10

GUDID 08809260475359

TRAUS BDI10/AAD10/MBD20NL UNIT CHAIR MOTOR SET

Saeshin Precision Co., Ltd.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 08809260475359
• NIH Device Record Key: 84d2eb9c-0d80-4b02-a4d0-42bbea515a75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDI10
• Version Model Number: SDI10
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809260475359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251407

FDA Product Code

• EBW: Controller, Foot, Handpiece And Cord

Sterilization

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

[08809260475359]

Moist Heat or Steam Sterilization

[08809260475359]

Moist Heat or Steam Sterilization

[08809260475359]

Moist Heat or Steam Sterilization

[08809260475359]

Moist Heat or Steam Sterilization

[08809260475359]

Moist Heat or Steam Sterilization

[08809260475359]

Moist Heat or Steam Sterilization

[08809260475359]

Moist Heat or Steam Sterilization

[08809260475359]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-12
• Device Publish Date: 2026-03-04

Devices Manufactured by Saeshin Precision Co., Ltd.

• 08809260470088 - TRAUS SUS10: 2026-03-30 32:1, optic XUS10/MBP10SL/CRB27LX/PEZ10XX/FUS10
• 08809260470095 - TRAUS SUS10: 2026-03-30 32:1, non-optic XUS10/MBP10SX/CRB27XX/PEZ10XX/FUS10
• 08809260470101 - TRAUS SUS10: 2026-03-30 20.:1, optic XUS10/MBP10SL/CRB26LX/PEZ10XX/FUS10
• 08809260470118 - TRAUS SUS10: 2026-03-30 20:1, Non-optic XUS10/MBP10SX/CRB26XX/PEZ10XX/FUS10
• 08809260475359 - SDI10: 2026-03-12TRAUS BDI10/AAD10/MBD20NL UNIT CHAIR MOTOR SET
• 08809260475359 - SDI10: 2026-03-12 TRAUS BDI10/AAD10/MBD20NL UNIT CHAIR MOTOR SET
• 08809260475137 - SIP20 FT Surgical System: 2025-12-11 BIP20ft
• 08809260475083 - SIP20 FT Surgical System: 2025-12-08 BIP20ft/MBP20SX/FUS10 SET
• 08809260475090 - SIP20 FT Surgical System: 2025-12-08 BIP20ft/MBP20SX/TST30NN04/FUS10 SET