The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Prompt L-pop.
Device ID | K984246 |
510k Number | K984246 |
Device Name: | PROMPT L-POP |
Classification | Agent, Tooth Bonding, 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 | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-27 |
Decision Date | 1999-01-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PROMPT L-POP 75639813 2699042 Dead/Cancelled |
ESPE Dental AG 1999-02-12 |