Pre-Milled Blank

GUDID 08800055700052

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800055700052
• NIH Device Record Key: 3e08c998-22ea-4cfe-9992-81a84aef82dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Milled Blank
• Version Model Number: CIHE136
• 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	08800055700052 [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

[08800055700052]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700052]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700052]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700052]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700052]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700052]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700052]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700052]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[08800055700052]

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