The following data is part of a premarket notification filed by Vita Zahnfabrik H. Rauter Gmbh Co. with the FDA for Vita Enamic Implant Solutions (is).
| Device ID | K153645 |
| 510k Number | K153645 |
| Device Name: | VITA ENAMIC Implant Solutions (IS) |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-06-30 |
| Summary: | summary |