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 |