27131

GUDID 04963931271313

The device is an instrument used when treating patients with reinfected root canal to remove gutta percha, etc. attached to the root canal walls.

YDM CORPORATION

Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable Manual dental scaler, reusable

• Primary Device ID: 04963931271313
• NIH Device Record Key: f66dca48-f6ad-4f20-b012-88dc6474e4e2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 27131
• Catalog Number: 27131
• Company DUNS: 716059766
• Company Name: YDM CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp
• Phone: +819019940653
• Email: jumpei@ydm.co.jp

Device Identifiers

Device Issuing Agency	Device ID
GS1	04963931271313 [Primary]

FDA Product Code

• EMN: Scaler, Periodontic

Sterilization

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

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

[04963931271313]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-16
• Device Publish Date: 2024-02-08

Devices Manufactured by YDM CORPORATION

• 04963931227211 - NA: 2024-04-09 Use to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure.
• 04963931227228 - NA: 2024-04-09 Use to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure.
• 04963931227266 - NA: 2024-04-09 Use to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure.
• 04963931276103 - NA: 2024-04-09 The intended medical indication is to use to hold or to fix or to remove small objects or to bend or to cut metal strips or wire
• 04963931102013 - NA: 2024-02-16 This device is a handle for attaching the working end of dental medical devices manufactured by YDM.
• 04963931102020 - NA: 2024-02-16 This device is a handle for attaching the working end of dental medical devices manufactured by YDM.
• 04963931102037 - NA: 2024-02-16 This device is a handle for attaching the working end of dental medical devices manufactured by YDM.
• 04963931102051 - NA: 2024-02-16 This device is a handle for attaching the working end of dental medical devices manufactured by YDM.