The following data is part of a premarket notification filed by Sulzer Dental, Inc. with the FDA for Advent Implant System, Swiss Plus Implant System.
| Device ID | K011245 |
| 510k Number | K011245 |
| Device Name: | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SULZER DENTAL, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Foster Boop |
| Correspondent | Foster Boop SULZER DENTAL, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2001-06-25 |