The following data is part of a premarket notification filed by Dmp Ltd with the FDA for Dmp Etching Gel.
Device ID | K102255 |
510k Number | K102255 |
Device Name: | DMP ETCHING GEL |
Classification | Material, Tooth Shade, Resin |
Applicant | DMP LTD KALYVION AVENUE MARKOPOULO INDUSTRIAL ZONE Markopoulo, Attiki, GR 19003 |
Contact | Dimitris Prantsidis |
Correspondent | Dimitris Prantsidis DMP LTD KALYVION AVENUE MARKOPOULO INDUSTRIAL ZONE Markopoulo, Attiki, GR 19003 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-10 |
Decision Date | 2010-11-23 |