The following data is part of a premarket notification filed by Adin Dental Implants System Ltd with the FDA for Adin Dental Implants System.
Device ID | K081751 |
510k Number | K081751 |
Device Name: | ADIN DENTAL IMPLANTS SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | ADIN DENTAL IMPLANTS SYSTEM LTD INDUSTRIAL PARK 13 M.P. MISGAV Mizpe Aviv, IL 20187 |
Contact | Benny Arazy |
Correspondent | Benny Arazy ADIN DENTAL IMPLANTS SYSTEM LTD INDUSTRIAL PARK 13 M.P. MISGAV Mizpe Aviv, IL 20187 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-19 |
Decision Date | 2008-12-19 |