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 |