The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Espe Haur.
Device ID | K010781 |
510k Number | K010781 |
Device Name: | 3M ESPE HAUR |
Classification | Material, Tooth Shade, Resin |
Applicant | 3M COMPANY 3M CENTER, BLDG. 260-2B-12 St Paul, MN 55144 |
Contact | Scott Erickson |
Correspondent | Scott Erickson 3M COMPANY 3M CENTER, BLDG. 260-2B-12 St Paul, MN 55144 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-15 |
Decision Date | 2001-04-13 |