Arena

GUDID 08800055704777

ARUM DENTISTRY Co., Ltd.

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• Primary Device ID: 08800055704777
• NIH Device Record Key: f224debb-7f74-448a-817a-1d10cdb83830
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arena
• Version Model Number: FM-D22-A2
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800055704777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190112

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-14
• Device Publish Date: 2023-12-06

On-Brand Devices [Arena]

• 08800055704609: FM-D26
• 08800055704593: FM-D25
• 08800055704586: FM-D24
• 08800055704579: FM-D22
• 08800055704562: FM-D20
• 08800055704555: FM-D18
• 08800055704548: FM-D16
• 08800055704531: FM-D14
• 08800055704524: FM-D12
• 08800055704517: FM-D10
• 08800055704500: DC9826A35
• 08800055704494: DC9825A35
• 08800055704487: DC9824A35
• 08800055704470: DC9822A35
• 08800055704463: DC9820A35
• 08800055704456: DC9818A35
• 08800055704449: DC9816A35
• 08800055704432: DC9814A35
• 08800055704425: DC9812A35
• 08800055704418: DC9810A35
• 08800055704401: DC9826A3
• 08800055704395: DC9825A3
• 08800055704388: DC9824A3
• 08800055704371: DC9822A3
• 08800055704364: DC9820A3
• 08800055704357: DC9818A3
• 08800055704340: DC9816A3
• 08800055704333: DC9814A3
• 08800055704326: DC9812A3
• 08800055704319: DC9810A3
• 08800055704302: DC9826A2
• 08800055704296: DC9825A2
• 08800055704289: DC9824A2
• 08800055704272: DC9822A2
• 08800055704265: DC9820A2
• 08800055704258: DC9818A2
• 08800055704241: DC9816A2
• 08800055704234: DC9814A2
• 08800055704227: DC9812A2
• 08800055704210: DC9810A2
• 08800055704203: DC9826A1
• 08800055704197: DC9825A1
• 08800055704180: DC9824A1
• 08800055704173: DC9822A1
• 08800055704166: DC9820A1
• 08800055704159: DC9818A1
• 08800055704142: DC9816A1
• 08800055704135: DC9814A1
• 08800055704128: DC9812A1
• 08800055704111: DC9810A1