COSMIC

Alloy, Gold-based Noble Metal

JENERIC/PENTRON, INC.

The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Cosmic.

Pre-market Notification Details

• Device ID: K010044
• 510k Number: K010044
• Device Name: COSMIC
• Classification: Alloy, Gold-based Noble Metal
• Applicant: JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724
• Contact: Annmarie Tenero
• Correspondent: Annmarie Tenero; JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724
• Product Code: EJT
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-05
• Decision Date: 2001-02-09