HERMES

Material, Tooth Shade, Resin

3M ESPE AG DENTAL PRODUCTS

The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Hermes.

Pre-market Notification Details

• Device ID: K033996
• 510k Number: K033996
• Device Name: HERMES
• Classification: Material, Tooth Shade, Resin
• Applicant: 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229
• Contact: Andreas Petermann
• Correspondent: Andreas Petermann; 3M ESPE AG DENTAL PRODUCTS 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: 2003-12-24
• Decision Date: 2004-02-24
• Summary: summary