The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Palaxpress Ultra Powder (pink); Palaxpress Ultra Liquid.
| Device ID | K110037 |
| 510k Number | K110037 |
| Device Name: | PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Contact | Cheryl Zimmerman |
| Correspondent | Cheryl Zimmerman HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-06 |
| Decision Date | 2011-04-29 |
| Summary: | summary |