ALERT

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 Alert.

Pre-market Notification Details

• Device ID: K974131
• 510k Number: K974131
• Device Name: ALERT
• Classification: Material, Tooth Shade, Resin
• Applicant: JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724
• Contact: Murray C Gamberg
• Correspondent: Murray C Gamberg; JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 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: 1997-11-03
• Decision Date: 1997-12-17