The following data is part of a premarket notification filed by Vita Zahnfabrik H. Rauter Gmbh & Co. with the FDA for Vita Vm Lc Flow.
Device ID | K152373 |
510k Number | K152373 |
Device Name: | VITA VM LC Flow |
Classification | Material, Tooth Shade, Resin |
Applicant | VITA ZAHNFABRIK H. RAUTER GMBH & CO. Spitelgasse 3 Bad Sackingen, DE D-79713 |
Contact | Bernd Walker |
Correspondent | Nevine Erian VITA North America, Inc. 22705 Savi Ranch Parkway Suite 100 Yorba Linda, CA 92887 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-21 |
Decision Date | 2015-12-30 |