The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for D.sign 59.
| Device ID | K013809 |
| 510k Number | K013809 |
| Device Name: | D.SIGN 59 |
| Classification | Alloy, Other Noble Metal |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Anderjeet Gulati |
| Correspondent | Anderjeet Gulati IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-15 |
| Decision Date | 2002-02-07 |