The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Zenostar Magic Glaze.
| Device ID | K103494 |
| 510k Number | K103494 |
| Device Name: | ZENOSTAR MAGIC GLAZE |
| Classification | Powder, Porcelain |
| Applicant | WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Contact | Gerhard Polzer |
| Correspondent | Gerhard Polzer WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-02-16 |