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 |