The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Cavit Lc.
Device ID | K990982 |
510k Number | K990982 |
Device Name: | CAVIT LC |
Classification | Material, Tooth Shade, Resin |
Applicant | ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Andreas Petermann |
Correspondent | Andreas Petermann ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-24 |
Decision Date | 1999-04-23 |
Summary: | summary |