Enamelize 906101

GUDID D7799061010

COSMEDENT, INC.

Dental abrasive powder

• Primary Device ID: D7799061010
• NIH Device Record Key: 8adb89bd-087b-476a-9899-db096ac9241a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enamelize
• Version Model Number: 906101
• Catalog Number: 906101
• 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	D7799061010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862912

FDA Product Code

• EJR: Agent, Polishing, Abrasive, Oral Cavity

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 [Enamelize]

• D7799061010: 906101
• D7799060000: 906000