The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Multilink Hybrid Abutment Cement.
| Device ID | K130436 |
| 510k Number | K130436 |
| Device Name: | MULTILINK HYBRID ABUTMENT CEMENT |
| Classification | Cement, Dental |
| Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT AG 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 | 2013-02-21 |
| Decision Date | 2013-08-20 |
| Summary: | summary |