Cemented Abutment

GUDID 08800049235706

DIO Corporation

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800049235706
• NIH Device Record Key: 0f01f4ee-bb6b-44b7-88e8-31ebeba30d75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cemented Abutment
• Version Model Number: AMI 35017N[H]
• Company DUNS: 631085206
• Company Name: DIO Corporation
• Device Count: 1
• DM Exempt: true
• 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	08800049235706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070570

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

[08800049235706]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-23
• Device Publish Date: 2025-09-15

On-Brand Devices [Cemented Abutment]

• 08800049237960: AMN 40528N[H]
• 08800049236192: AMI 48037N[H]
• 08800049236093: AMI 48027N[H]
• 08800049235997: AMI 48017N[H]
• 08800049235874: AMI 48007N[H]
• 08800049235829: AMI 35037N[H]
• 08800049235768: AMI 35027N[H]
• 08800049235706: AMI 35017N[H]
• 08800049235645: AMI 35007N[H]