The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Quik Temp Temporization Material.
Device ID | K001114 |
510k Number | K001114 |
Device Name: | 3M QUIK TEMP TEMPORIZATION MATERIAL |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Contact | Cheri Smokovich |
Correspondent | Cheri Smokovich 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-06 |
Decision Date | 2000-06-09 |