The following data is part of a premarket notification filed by Sybron Implant Solutions Gmbh with the FDA for Pitt-easy Dental Implant System.
| Device ID | K083297 |
| 510k Number | K083297 |
| Device Name: | PITT-EASY DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SYBRON IMPLANT SOLUTIONS GMBH 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman SYBRON IMPLANT SOLUTIONS GMBH 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-01-28 |
| Summary: | summary |