The following data is part of a premarket notification filed by Dentaurum with the FDA for Contec Light.
Device ID | K030641 |
510k Number | K030641 |
Device Name: | CONTEC LIGHT |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | DENTAURUM 10 PHEASANT RUN Newtown, PA 18940 |
Contact | Jan W A. Doorschodt |
Correspondent | Jan W A. Doorschodt DENTAURUM 10 PHEASANT RUN Newtown, PA 18940 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-28 |
Decision Date | 2003-06-10 |