The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Ivobase Cad For Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid.
| Device ID | K151142 |
| 510k Number | K151142 |
| Device Name: | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | WIELAND DENTAL + TECHNIK GMBH & CO. KG Lindenstr.2 Pforzheim, DE D-75175 |
| Contact | Betina Kistner |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-29 |
| Decision Date | 2015-08-13 |
| Summary: | summary |