The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Curay-match Paint-on Composite Restor.
Device ID | K833810 |
510k Number | K833810 |
Device Name: | CURAY-MATCH PAINT-ON COMPOSITE RESTOR |
Classification | Material, Tooth Shade, Resin |
Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 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 | 1983-11-02 |
Decision Date | 1984-02-21 |