The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Polylux Ii.
| Device ID | K013500 |
| 510k Number | K013500 |
| Device Name: | KAVO POLYLUX II |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Contact | Jennifer Pottala |
| Correspondent | Jennifer Pottala KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2002-01-14 |
| Summary: | summary |