MALTA

Cement, Dental

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 Malta.

Pre-market Notification Details

• Device ID: K100756
• 510k Number: K100756
• Device Name: MALTA
• Classification: Cement, Dental
• Applicant: 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229
• Contact: Desi Soegiarto
• Correspondent: Desi Soegiarto; 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-17
• Decision Date: 2010-06-02
• Summary: summary