OptiComp

Material, Tooth Shade, Resin

Pac-Dent, Inc.

The following data is part of a premarket notification filed by Pac-dent, Inc. with the FDA for Opticomp.

Pre-market Notification Details

• Device ID: K202920
• 510k Number: K202920
• Device Name: OptiComp
• Classification: Material, Tooth Shade, Resin
• Applicant: Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821
• Contact: Jiahe Li
• Correspondent: Jingtian (Tom) Peng; Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-29
• Decision Date: 2022-05-25