The following data is part of a premarket notification filed by A.b. Dental Devices, Ltd. with the FDA for A.b. Dental Devices Dental Implants System.
Device ID | K132125 |
510k Number | K132125 |
Device Name: | A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | A.B. DENTAL DEVICES, LTD. 22817 VENTURA BLVD #161 Woodland Hills, CA 91364 |
Contact | Daniela Levy |
Correspondent | Daniela Levy A.B. DENTAL DEVICES, LTD. 22817 VENTURA BLVD #161 Woodland Hills, CA 91364 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-10 |
Decision Date | 2014-01-21 |
Summary: | summary |