The following data is part of a premarket notification filed by 3m Espe Ag with the FDA for Flash Bite.
| Device ID | K133400 |
| 510k Number | K133400 |
| Device Name: | FLASH BITE |
| Classification | Material, Impression |
| Applicant | 3M ESPE AG ESPE PLATZ Seefeld, DE D-82229 |
| Contact | Ruediger Franke |
| Correspondent | Ruediger Franke 3M ESPE AG ESPE PLATZ Seefeld, DE D-82229 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-06 |
| Decision Date | 2014-03-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLASH BITE 85061095 not registered Dead/Abandoned |
Bryan Gouthro 2010-06-11 |