The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Kerr Cavalite.
Device ID | K872147 |
510k Number | K872147 |
Device Name: | KERR CAVALITE |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | KERR CORPORATION (DANBURY) ONE THOMAS CIRCLE Washington, DC 20005 |
Contact | Kurzman, Pc |
Correspondent | Kurzman, Pc KERR CORPORATION (DANBURY) ONE THOMAS CIRCLE Washington, DC 20005 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-04 |
Decision Date | 1987-08-26 |