The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Nexus Universal Self-cure.
| Device ID | K191548 |
| 510k Number | K191548 |
| Device Name: | Nexus Universal Self-Cure |
| Classification | Cement, Dental |
| Applicant | Kerr Corporation 1717 W. Collins Ave Orange, CA 92867 |
| Contact | Ardrena Jackson |
| Correspondent | Ardrena Jackson Sybron Dental Specialties 1717 W. Collins Ave. 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 | 2019-06-12 |
| Decision Date | 2019-10-11 |
| Summary: | summary |