21080

GUDID 04963931210800

The intended medical indication is grasping and removing a crown that has been tried into the oral cavity.

YDM CORPORATION

Dental prosthesis removal instrument

• Primary Device ID: 04963931210800
• NIH Device Record Key: 68fc223a-9935-45ac-94d1-af09e7a3c3e2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 21080
• Catalog Number: 21080
• 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	04963931210800 [Primary]

FDA Product Code

• EIS: Remover, Crown

Sterilization

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

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

[04963931210800]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-12-05

Devices Manufactured by YDM CORPORATION

• 04963931210794 - NA: 2025-12-15 The intended medical indication is grasping and removing a crown that has been tried into the oral cavity.
• 04963931210800 - NA: 2025-12-15The intended medical indication is grasping and removing a crown that has been tried into the oral cavity.
• 04963931210800 - NA: 2025-12-15 The intended medical indication is grasping and removing a crown that has been tried into the oral cavity.
• 04963931274291 - NA: 2025-07-21 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
• 04963931274659 - NA: 2025-04-11 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
• 04963931274666 - NA: 2025-04-11 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
• 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.