The following data is part of a premarket notification filed by Biomate Medical Devices Technology Co., Ltd. with the FDA for Biomate Dental Implant System.
| Device ID | K142174 |
| 510k Number | K142174 |
| Device Name: | BIOMATE DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. 1F., NO.59, LUKE 2ND RD., LUZHU TOWNSHIP Kaohsiung County, TW 820 |
| Contact | Wayne Chen |
| Correspondent | Wayne Chen BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. 1F., NO.59, LUKE 2ND RD., LUZHU TOWNSHIP Kaohsiung County, TW 820 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-07 |
| Decision Date | 2015-03-20 |
| Summary: | summary |