TRAUS Air Dental Handpiece

GUDID 08809260471801

TRAUS ATN400 / CP10NQ

Saeshin Precision Co., Ltd.

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 08809260471801
• NIH Device Record Key: f3f745be-9cfc-4576-bb19-c97cae05676c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAUS Air Dental Handpiece
• Version Model Number: TRAUS ATN400
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809260471801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221741

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

[08809260471801]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-29
• Device Publish Date: 2025-05-21

On-Brand Devices [TRAUS Air Dental Handpiece]

• 08809260473386: CAB20ND M4
• 08809260473379: CAB20ND B2
• 08809260473027: TRAUS CAB10LK
• 08809260473010: TRAUS CAB10LN
• 08809260473003: TRAUS ATN400
• 08809260471832: TRAUS CAB10LK / CP10LK
• 08809260471818: TRAUS CAB10LN / CP10LN
• 08809260471801: TRAUS ATN400 / CP10NQ