The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Aquasil Ultra Monophase/heavy/lv Smart Wetting Impression Material.
| Device ID | K021416 |
| 510k Number | K021416 |
| Device Name: | AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-03 |
| Decision Date | 2002-05-13 |
| Summary: | summary |