PROCEM

GUDID M737P97401

Procem Activator

Ototronix, LLC

Glass ionomer dental cement

• Primary Device ID: M737P97401
• NIH Device Record Key: b14d9e2a-4002-4798-8d24-f9c6eee5e57b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROCEM
• Version Model Number: P9740
• 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	M737P97401 [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