PROCOM

Material, Tooth Shade, Resin

JENERIC/PENTRON, INC.

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

Pre-market Notification Details

• Device ID: K941378
• 510k Number: K941378
• Device Name: PROCOM
• Classification: Material, Tooth Shade, Resin
• Applicant: JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724
• Contact: Linda D Rivard
• Correspondent: Linda D Rivard; JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-22
• Decision Date: 1994-05-02