CAVITRON

Cement, Dental

G-C INTL. CORP.

The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for Cavitron.

Pre-market Notification Details

• Device ID: K812568
• 510k Number: K812568
• Device Name: CAVITRON
• Classification: Cement, Dental
• Applicant: G-C INTL. CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-09-09
• Decision Date: 1981-09-25