The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Demi Ultra.
| Device ID | K163064 |
| 510k Number | K163064 |
| Device Name: | Demi Ultra |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | KERR CORPORATION 1717 W. COLLINS AVE Orange, CA 92867 |
| Contact | Mohammad Saad Ansari |
| Correspondent | Mohammad Saad Ansari SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVE Orange, CA 92867 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-02 |
| Decision Date | 2017-07-18 |
| Summary: | summary |