PROCEM 986-004

GUDID M7379860041

Procem Amalgamator - Grace Medical

Ototronix, LLC

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: M7379860041
• NIH Device Record Key: 850f1bcf-95d9-4700-9ecf-93760157d69a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROCEM
• Version Model Number: 986-004
• Catalog Number: 986-004
• Company DUNS: 833067478
• Company Name: Ototronix, LLC
• 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: 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
HIBCC	M7379860041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140644

FDA Product Code

• NEA: Cement, Ear, Nose And Throat

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-10
• Device Publish Date: 2020-12-02

On-Brand Devices [PROCEM]

• M737P97401: Procem Activator
• M737P97301: Procem Applicator
• M737P97201: Procem Mixer
• M7379860041: Procem Amalgamator - Grace Medical
• M7379860031: Procem Activator - Grace Medical
• M7379860021: Procem Applicator - Grace Medical
• M7379860011: Procem Cement - Grace Medical