The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Zenolux.
| Device ID | K130184 |
| 510k Number | K130184 |
| Device Name: | ZENOLUX |
| Classification | Powder, Porcelain |
| Applicant | WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRASSE 13 Pforzheim, DE 75179 |
| Contact | Gerhard Polzer |
| Correspondent | Gerhard Polzer WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRASSE 13 Pforzheim, DE 75179 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-25 |
| Decision Date | 2013-05-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZENOLUX 79131007 4508670 Live/Registered |
Wieland Dental + Technik GmbH & Co. KG 2013-04-17 |