The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Unicem.
Device ID | K094007 |
510k Number | K094007 |
Device Name: | UNICEM |
Classification | Cement, Dental |
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 | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-28 |
Decision Date | 2010-04-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UNICEM 76377238 2868333 Live/Registered |
3M DEUTSCHLAND GMBH 2002-02-28 |
UNICEM 75079730 not registered Dead/Abandoned |
Holderness, Stephen 1996-03-28 |
UNICEM 74723221 2150009 Dead/Cancelled |
Unicem S.p.A. 1995-08-31 |