The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Xantasil Dynamix Fast Set Cartridge -2 X 380ml; Xantasil Fast Set Cartridge -6 X 50ml.
| Device ID | K130647 |
| 510k Number | K130647 |
| Device Name: | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML |
| Classification | Material, Impression |
| Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Contact | Jamie Mearna |
| Correspondent | Jamie Mearna HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-05-17 |
| Summary: | summary |