FIBERBOND

Maintainer, Space Preformed, Orthodontic

DENTEC, INC.

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

Pre-market Notification Details

• Device ID: K864376
• 510k Number: K864376
• Device Name: FIBERBOND
• Classification: Maintainer, Space Preformed, Orthodontic
• Applicant: DENTEC, INC. P.O. BOX 296 Roslyn, NY 11576
• Product Code: DYT
• CFR Regulation Number: 872.5525 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-11-05
• Decision Date: 1987-04-07