C&B 5.0 Hybrid

GUDID 08800055726953

ARUM DENTISTRY Co., Ltd.

Temporary dental crown/bridge resin

• Primary Device ID: 08800055726953
• NIH Device Record Key: f589081b-5901-42a6-adf9-b9a3ead3e560
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C&B 5.0 Hybrid
• Version Model Number: C&B 5.0 Hybrid-1000
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• 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	08800055726953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210817

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2026-03-18
• Device Publish Date: 2026-03-10

On-Brand Devices [C&B 5.0 Hybrid]

• 08800055726953: C&B 5.0 Hybrid-1000
• 08800055726946: C&B 5.0 Hybrid-500