The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Sinfony.
Device ID | K992645 |
510k Number | K992645 |
Device Name: | SINFONY |
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 | 1999-08-06 |
Decision Date | 1999-09-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SINFONY 75255911 2182004 Live/Registered |
3M DEUTSCHLAND GMBH 1997-03-12 |