The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Elegant.
Device ID | K091826 |
510k Number | K091826 |
Device Name: | ELEGANT |
Classification | Powder, Porcelain |
Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Desi W Soegiarto |
Correspondent | Desi W Soegiarto 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-19 |
Decision Date | 2009-09-25 |
Summary: | summary |