The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Demi Ultra.
| Device ID | K123468 |
| 510k Number | K123468 |
| Device Name: | DEMI ULTRA |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-09 |
| Decision Date | 2013-03-20 |
| Summary: | summary |