The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Systemp.link.
| Device ID | K042846 |
| 510k Number | K042846 |
| Device Name: | SYSTEMP.LINK |
| Classification | Cement, Dental |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-15 |
| Decision Date | 2004-12-20 |