HYDROL

Varnish, Cavity

SEPTODONT, INC.

The following data is part of a premarket notification filed by Septodont, Inc. with the FDA for Hydrol.

Pre-market Notification Details

• Device ID: K760660
• 510k Number: K760660
• Device Name: HYDROL
• Classification: Varnish, Cavity
• Applicant: SEPTODONT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: LBH
• CFR Regulation Number: 872.3260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1976-09-15
• Decision Date: 1976-09-27