Cemented Cylinder MCEM 5408H

GUDID 08800049251225

DIO Corporation

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800049251225
• NIH Device Record Key: 3e8e4cf8-d228-4928-b289-bed4be197b2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cemented Cylinder
• Version Model Number: MCEM 5408H
• Catalog Number: MCEM 5408H
• Company DUNS: 631085206
• Company Name: DIO Corporation
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08800049251225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182194

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800049251225]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-18
• Device Publish Date: 2020-03-10

On-Brand Devices [Cemented Cylinder]

• 08800049251232: MCEM 5408N
• 08800049251225: MCEM 5408H