The following data is part of a premarket notification filed by Dental Products Of Usa, Inc. with the FDA for Power Led.
Device ID | K033697 |
510k Number | K033697 |
Device Name: | POWER LED |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | DENTAL PRODUCTS OF USA, INC. 1460 N.W. 107 AVE., SUITE G Miami, FL 33174 |
Contact | George Echeverri |
Correspondent | George Echeverri DENTAL PRODUCTS OF USA, INC. 1460 N.W. 107 AVE., SUITE G Miami, FL 33174 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-25 |
Decision Date | 2004-02-27 |
Summary: | summary |