Prevue 604104

GUDID D7796041040

COSMEDENT, INC.

Dental cement trial

• Primary Device ID: D7796041040
• NIH Device Record Key: 22c01c77-ccc2-4db5-9d3c-633b9d9eb67f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prevue
• Version Model Number: 604104
• Catalog Number: 604104
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
HIBCC	D7796041040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894477

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-22

On-Brand Devices [Prevue]

• D7796041070: 604107
• D7796041060: 604106
• D7796041050: 604105
• D7796041040: 604104
• D7796041030: 604103
• D7796041020: 604102
• D7796041010: 604101