The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Ips E.max Cad Crystall / Connect And Ips E.max Cad Crystal / Add-on Connect (for Cad-on Technique).
| Device ID | K103556 |
| 510k Number | K103556 |
| Device Name: | IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) |
| Classification | Powder, Porcelain |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-02 |
| Decision Date | 2011-04-13 |