The following data is part of a premarket notification filed by Bhdental Ltd with the FDA for Bhdental Implant System.
Device ID | K103280 |
510k Number | K103280 |
Device Name: | BHDENTAL IMPLANT SYSTEM |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | BHDENTAL LTD 21 HANAFA STREET Zur-moshe, IL 42810 |
Contact | Eilat Ezra |
Correspondent | Eilat Ezra BHDENTAL LTD 21 HANAFA STREET Zur-moshe, IL 42810 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-05 |
Decision Date | 2011-02-24 |
Summary: | summary |