Pre-Milled Blank

GUDID 08800055700045

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800055700045
• NIH Device Record Key: 25e796bf-d73f-4602-980e-c3d4eae747b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Milled Blank
• Version Model Number: CIHE135
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800055700045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193425

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700045]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-27
• Device Publish Date: 2020-04-17

On-Brand Devices [Pre-Milled Blank]

• 08800055700052: CIHE136
• 08800055700045: CIHE135
• 08800055700038: CIHE040
• 08800055700021: CIHE039
• 08800055700014: CIHE038
• 08800055700007: CIHE037