The following data is part of a premarket notification filed by A.b. Dental Devices, Ltd. with the FDA for Ab Dental Devices Implants And Accessories.
Device ID | K112440 |
510k Number | K112440 |
Device Name: | AB DENTAL DEVICES IMPLANTS AND ACCESSORIES |
Classification | Implant, Endosseous, Root-form |
Applicant | A.B. DENTAL DEVICES, LTD. POB 367 Ramat Hasharon,, IL 47103 |
Contact | Charles Hurwitz |
Correspondent | Charles Hurwitz A.B. DENTAL DEVICES, LTD. POB 367 Ramat Hasharon,, IL 47103 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-24 |
Decision Date | 2012-04-18 |
Summary: | summary |