The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Kerr Herculite Dental Composite Restorative Materi.
Device ID | K844662 |
510k Number | K844662 |
Device Name: | KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI |
Classification | Material, Tooth Shade, Resin |
Applicant | KERR CORPORATION (DANBURY) SUITE 1200 Washington, DC 20005 |
Contact | Stephen Kurzman |
Correspondent | Stephen Kurzman KERR CORPORATION (DANBURY) SUITE 1200 Washington, DC 20005 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-30 |
Decision Date | 1985-03-25 |