The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Protemp 3 Garant.
Device ID | K033022 |
510k Number | K033022 |
Device Name: | PROTEMP 3 GARANT |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Andreas Petermann |
Correspondent | Andreas Petermann 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-25 |
Decision Date | 2003-11-21 |
Summary: | summary |