The following data is part of a premarket notification filed by Biomedical Implant Technology, Inc. with the FDA for Kwan Hexagonal Abutment Implant System (hais).
| Device ID | K962753 |
| 510k Number | K962753 |
| Device Name: | KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOMEDICAL IMPLANT TECHNOLOGY, INC. 10304 ISLANDER DR. Boca Raton, FL 33498 |
| Contact | Ronald Mccarley |
| Correspondent | Ronald Mccarley BIOMEDICAL IMPLANT TECHNOLOGY, INC. 10304 ISLANDER DR. Boca Raton, FL 33498 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-15 |
| Decision Date | 1997-05-19 |