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 |