The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Dent Ii System.
| Device ID | K981647 |
| 510k Number | K981647 |
| Device Name: | 3M DENT II SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Contact | Leal Pickett |
| Correspondent | Leal Pickett 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-11 |
| Decision Date | 1998-08-09 |
| Summary: | summary |