The following data is part of a premarket notification filed by Paltop Advanced Dental Solutions Ltd with the FDA for Paltop Dental Implant System.
Device ID | K112795 |
510k Number | K112795 |
Device Name: | PALTOP DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | PALTOP ADVANCED DENTAL SOLUTIONS LTD 5 HASHITA STREET Caesarea, IL Is |
Contact | Tal Hammer-topaz |
Correspondent | Tal Hammer-topaz PALTOP ADVANCED DENTAL SOLUTIONS LTD 5 HASHITA STREET Caesarea, IL Is |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-26 |
Decision Date | 2012-04-20 |
Summary: | summary |