FLOW-RITE

Material, Tooth Shade, Resin

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Flow-rite.

Pre-market Notification Details

• Device ID: K971594
• 510k Number: K971594
• Device Name: FLOW-RITE
• Classification: Material, Tooth Shade, Resin
• Applicant: PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780
• Contact: Kenneth J Berk
• Correspondent: Kenneth J Berk; PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-01
• Decision Date: 1997-09-12
• Summary: summary