The following data is part of a premarket notification filed by 3m Espe Ag with the FDA for Adhesive Exl-759.
Device ID | K110302 |
510k Number | K110302 |
Device Name: | ADHESIVE EXL-759 |
Classification | Agent, Tooth Bonding, Resin |
Applicant | 3M ESPE AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Desi W Soegiarto |
Correspondent | Desi W Soegiarto 3M ESPE 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 | 2011-02-02 |
Decision Date | 2011-05-19 |
Summary: | summary |