The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Rely X Veneer Cement Try-in Paster.
Device ID | K002452 |
510k Number | K002452 |
Device Name: | 3M RELY X VENEER CEMENT TRY-IN PASTER |
Classification | Cement, Dental |
Applicant | 3M COMPANY 3M CENTER, BLDG. 260-2B-12 St Paul, MN 55144 |
Contact | Shannon Pettit |
Correspondent | Shannon Pettit 3M COMPANY 3M CENTER, BLDG. 260-2B-12 St Paul, MN 55144 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-10 |
Decision Date | 2000-09-28 |