PROVICOL

Cement, Dental

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Provicol.

Pre-market Notification Details

• Device ID: K915618
• 510k Number: K915618
• Device Name: PROVICOL
• Classification: Cement, Dental
• Applicant: VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203
• Contact: Gail Gillenwater
• Correspondent: Gail Gillenwater; VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-12-16
• Decision Date: 1992-02-25