The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Supro 100.
Device ID | K151144 |
510k Number | K151144 |
Device Name: | SuPro 100 |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, DE 82234 |
Contact | Desi W. Soegiarto |
Correspondent | Desi W. Soegiarto 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, DE 82234 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-29 |
Decision Date | 2015-09-14 |
Summary: | summary |