Elements

Material, Impression

PAC-DENT INTERNATIONAL, INC.

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

Pre-market Notification Details

• Device ID: K151150
• 510k Number: K151150
• Device Name: Elements
• Classification: Material, Impression
• Applicant: PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE Brea, CA 92821
• Contact: Wenying Zhu
• Correspondent: Wenying Zhu; PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE Brea, CA 92821
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-30
• Decision Date: 2015-07-28
• Summary: summary