The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Flash Ar Penta / Flash Ar Penta Quick.
| Device ID | K131404 |
| 510k Number | K131404 |
| Device Name: | FLASH AR PENTA / FLASH AR PENTA QUICK |
| Classification | Material, Impression |
| Applicant | 3M DEUTSCHLAND GMBH ESPE PLATZ, 82229 Seefeld, DE Gm |
| Contact | Desi W Soegiarto |
| Correspondent | Alexander Schapovalov TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-05-30 |
| Summary: | summary |