The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Zeon Composite Resin Light Cure Sys.
Device ID | K820028 |
510k Number | K820028 |
Device Name: | ZEON COMPOSITE RESIN LIGHT CURE SYS |
Classification | Material, Tooth Shade, Resin |
Applicant | NATIONAL PATENT DEVELOPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-05 |
Decision Date | 1982-03-11 |