The following data is part of a premarket notification filed by Champions Implants Gmbh with the FDA for Champions Implants Gmbh Mimi 1-piece Precision Implant, Model 1000 Up To 6000.
| Device ID | K091182 |
| 510k Number | K091182 |
| Device Name: | CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CHAMPIONS IMPLANTS GMBH JAHNSTRASSE 14 Tuningen, Baden-wuerttemberg, DE 78609 |
| Contact | Marcus Weinacker |
| Correspondent | Marcus Weinacker CHAMPIONS IMPLANTS GMBH JAHNSTRASSE 14 Tuningen, Baden-wuerttemberg, DE 78609 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2010-01-07 |
| Summary: | summary |