Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K233194
TS Abutment System · Osstem Implant Co., Ltd. · decided 2024-02-20 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ET Multi Angled Abutment | ETMA517SHW | HIOSSEN, INC. | NHA | 00810125999116 |
| EK MULTI ANGLED ABUTMENT | ET30MUA485MWH | HIOSSEN, INC. | NHA | 00810126047052 |
| EK MULTI ANGLED ABUTMENT | ET30MUA484RWH | HIOSSEN, INC. | NHA | 00810126047045 |
| EK MULTI ANGLED ABUTMENT | ET30MUA484MWH | HIOSSEN, INC. | NHA | 00810126047038 |
| EK MULTI ANGLED ABUTMENT | ET30MUA483RWH | HIOSSEN, INC. | NHA | 00810126047021 |
| EK MULTI ANGLED ABUTMENT | ET30MUA483MWH | HIOSSEN, INC. | NHA | 00810126047014 |
| EK MULTI ANGLED ABUTMENT | ET17MUA485RWH | HIOSSEN, INC. | NHA | 00810126047007 |
| EK MULTI ANGLED ABUTMENT | ET17MUA484MWH | HIOSSEN, INC. | NHA | 00810126046987 |
| EK MULTI ANGLED ABUTMENT | ET17MUA482RWH | HIOSSEN, INC. | NHA | 00810126046956 |
| EK MULTI ANGLED ABUTMENT | ET30MUA485RWH | HIOSSEN, INC. | NHA | 00810126047069 |
| EK MULTI ANGLED ABUTMENT | ET17MUA484RWH | HIOSSEN, INC. | NHA | 00810126046994 |
| EK MULTI ANGLED ABUTMENT | ET17MUA483RWH | HIOSSEN, INC. | NHA | 00810126046970 |
| EK MULTI ANGLED ABUTMENT | ET17MUA483MWH | HIOSSEN, INC. | NHA | 00810126046963 |
| EK MULTI ANGLED ABUTMENT | ET17MUA482MWH | HIOSSEN, INC. | NHA | 00810126046949 |