The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Sustel Dental System.
Device ID | K970500 |
510k Number | K970500 |
Device Name: | 3M SUSTEL DENTAL SYSTEM |
Classification | Material, Tooth Shade, Resin |
Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Contact | Rebecca L Hannack |
Correspondent | Rebecca L Hannack 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 | 1997-02-10 |
Decision Date | 1997-04-30 |