The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Aquasil Ultra Smart Wetting Impression Material.
| Device ID | K113406 |
| 510k Number | K113406 |
| Device Name: | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST., SE 60 SUSQUEHANNA COMMERCE CTR. York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST., SE 60 SUSQUEHANNA COMMERCE CTR. York, PA 17404 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-18 |
| Decision Date | 2012-02-13 |
| Summary: | summary |