The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Accu-dent Xd Tray, Accu-dent Xd Syringe.
| Device ID | K143575 |
| 510k Number | K143575 |
| Device Name: | Accu-Dent XD Tray, Accu-Dent XD Syringe |
| Classification | Material, Impression |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-17 |
| Decision Date | 2015-04-03 |
| Summary: | summary |