The following data is part of a premarket notification filed by Dentply International Inc. with the FDA for Aquasil Ultra + Smart Wetting Impression Material.
| Device ID | K152861 |
| 510k Number | K152861 |
| Device Name: | Aquasil Ultra + Smart Wetting Impression Material |
| Classification | Material, Impression |
| Applicant | DENTPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA STREET, SUITE 60 York, PA 17405 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA STREET, SUITE 60 York, PA 17405 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-03-04 |
| Summary: | summary |