The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Zenostar Mo, Zenostar T, Zenostar Visualizr.
| Device ID | K142233 |
| 510k Number | K142233 |
| Device Name: | Zenostar MO, Zenostar T, Zenostar VisualiZr |
| Classification | Powder, Porcelain |
| Applicant | WIELAND DENTAL + TECHNIK GMBH & CO. KG Lindenstrasse 2 Pforzheim, DE D-75179 |
| Contact | Betina Kistner |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE 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 | 2014-08-13 |
| Decision Date | 2015-01-05 |
| Summary: | summary |