Insure 605108

GUDID D7796051080

COSMEDENT, INC.

Fatty acid dental cement

• Primary Device ID: D7796051080
• NIH Device Record Key: 902ef08e-5936-4dae-963f-7599e16d1bbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insure
• Version Model Number: 605108
• Catalog Number: 605108
• 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	D7796051080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873356

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Insure]

• D779605ACL0: 605ACL
• D7796051080: 605108
• D7796051070: 605107
• D7796051060: 605106
• D7796051050: 605105
• D7796051040: 605104
• D7796051030: 605103
• D7796051020: 605102
• D7796051010: 605101
• D7796021140: 602114
• D7796021080: 602108
• D7796021070: 602107
• D7796021060: 602106
• D7796021050: 602105
• D7796021040: 602104
• D7796021030: 602103
• D7796021020: 602102
• D7796021010: 602101