PROMPTFLOW

Material, Tooth Shade, Resin

ESPE DENTAL AG

The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Promptflow.

Pre-market Notification Details

• Device ID: K993566
• 510k Number: K993566
• Device Name: PROMPTFLOW
• Classification: Material, Tooth Shade, Resin
• Applicant: ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229
• Contact: Andreas Petermann
• Correspondent: Andreas Petermann; ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-10-21
• Decision Date: 1999-12-06
• Summary: summary