The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Nexus Rmgi.
Device ID | K123595 |
510k Number | K123595 |
Device Name: | NEXUS RMGI |
Classification | Cement, Dental |
Applicant | KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-21 |
Decision Date | 2013-02-19 |
Summary: | summary |