The following data is part of a premarket notification filed by Minnesota Mining And Mfg. Co. with the FDA for 3m Clinpro Prophy Paste, Model 12611.
Device ID | K990482 |
510k Number | K990482 |
Device Name: | 3M CLINPRO PROPHY PASTE, MODEL 12611 |
Classification | Agent, Polishing, Abrasive, Oral Cavity |
Applicant | MINNESOTA MINING AND MFG. CO. 3M CENTER St. Paul, MN 55144 -1000 |
Contact | Rebecca L Hannack |
Correspondent | Rebecca L Hannack MINNESOTA MINING AND MFG. CO. 3M CENTER St. Paul, MN 55144 -1000 |
Product Code | EJR |
CFR Regulation Number | 872.6030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-16 |
Decision Date | 1999-05-13 |
Summary: | summary |