The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Zenostar Mt, Zenostar Color Liquids.
| Device ID | K152118 |
| 510k Number | K152118 |
| Device Name: | Zenostar MT, Zenostar Color Liquids |
| Classification | Powder, Porcelain |
| Applicant | WIELAND DENTAL + TECHNIK GMBH & CO. KG LINDERSTRASSE 2 Pfozheim, DE 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 | 2015-07-30 |
| Decision Date | 2015-12-16 |
| Summary: | summary |