The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for Filtek Bulk Fill Posterior Restroative.
| Device ID | K141081 |
| 510k Number | K141081 |
| Device Name: | FILTEK BULK FILL POSTERIOR RESTROATIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | 3M ESPE DENTAL PRODUCTS 2510 CONWAY AVENUE Saint Paul, MN 55144 -0000 |
| Contact | Scott Erickson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-04-25 |
| Decision Date | 2014-05-08 |
| Summary: | summary |