The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Dent System.
Device ID | K962785 |
510k Number | K962785 |
Device Name: | 3M DENT SYSTEM |
Classification | Agent, Tooth Bonding, Resin |
Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Contact | Scott Erickson |
Correspondent | Scott Erickson 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-17 |
Decision Date | 1996-08-12 |
Summary: | summary |