The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Kerr Command Ultrafine Polishing Paste.
Device ID | K843022 |
510k Number | K843022 |
Device Name: | KERR COMMAND ULTRAFINE POLISHING PASTE |
Classification | Agent, Polishing, Abrasive, Oral Cavity |
Applicant | KERR CORPORATION (DANBURY) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJR |
CFR Regulation Number | 872.6030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-01 |
Decision Date | 1984-08-24 |