The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Dent System Ii Plus.
| Device ID | K973961 |
| 510k Number | K973961 |
| Device Name: | 3M DENT SYSTEM II PLUS |
| Classification | Cement, Dental |
| Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Contact | Lael J Pickett |
| Correspondent | Lael J Pickett 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-16 |
| Decision Date | 1997-12-17 |
| Summary: | summary |