The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Command Enamel-dent Dental Adhesive.
Device ID | K843025 |
510k Number | K843025 |
Device Name: | COMMAND ENAMEL-DENT DENTAL ADHESIVE |
Classification | Agent, Tooth Bonding, 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 | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-01 |
Decision Date | 1984-10-25 |