Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K182091
Osstem Abutment System · Osstem Implant Co., Ltd. · decided 2019-07-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Osstem Abutment System | TSPTA4050R | Osstem Implant Co., Ltd. | NHA | 08809917147295 |
| Osstem Abutment System | GSTAS4661WH | Osstem Implant Co., Ltd. | NHA | 08809892355623 |
| Osstem Abutment System | TSMC500NTH | Osstem Implant Co., Ltd. | NHA | 08800040616412 |
| ET Transfer Abutment | ETTA5064SHW | HIOSSEN, INC. | NHA | 00810019243165 |
| Osstem Abutment System | TS10PA454MWH | Osstem Implant Co., Ltd. | NHA | 08800121744706 |
| ET STUD ABUTMENT | ETSAO353S | HIOSSEN, INC. | NHA | 00810125999758 |
| ET Transfer Abutment | ETTA6075SHW | HIOSSEN, INC. | NHA | 00810019243363 |
| ET Transfer Abutment | ETTA4565SHW | HIOSSEN, INC. | NHA | 00810019243028 |
| ET Transfer Abutment | ETTA4065MHW | HIOSSEN, INC. | NHA | 00810019242922 |
| Osstem Abutment System | GSAA5020BWH | Osstem Implant Co., Ltd. | NHA | 08809892342692 |
| ET O-ring Lab Analog (Small) | ETOAL02 | HIOSSEN, INC. | NDP | 00810125999888 |
| ET Transfer Abutment | ETTA4567MNW | HIOSSEN, INC. | NHA | 00810019243059 |
| Osstem Abutment System | TSMN500NTH | Osstem Implant Co., Ltd. | NHA | 08809917073747 |
| ET Multi Ti Base | ETMTB0405G | HIOSSEN, INC. | NHA | 00810019244575 |
| ET Transfer Abutment | ETTA5065SNW | HIOSSEN, INC. | NHA | 00810019243196 |
| Multi Abutment NP-Cast Cylinder | ETMNCA500TH | HIOSSEN, INC. | NHA | 00810019242915 |
| Osstem Abutment System | TSMTBS | Osstem Implant Co., Ltd. | NHA | 08809917073860 |
| Osstem Abutment System | PTCM12S | Osstem Implant Co., Ltd. | NHA | 08809892364236 |
| Osstem Abutment System | GSTA4612NWH | Osstem Implant Co., Ltd. | NHA | 08809892350383 |
| Osstem Abutment System | GSAA4040MAWH | Osstem Implant Co., Ltd. | NHA | 08809892342265 |
| Osstem Abutment System | PTCM04S | Osstem Implant Co., Ltd. | NHA | 08800040608813 |
| Osstem Abutment System | GSTA4732WH | Osstem Implant Co., Ltd. | NHA | 08800040603276 |
| ET STUD ABUTMENT | ETSAO352S | HIOSSEN, INC. | NHA | 00810125999734 |
| Osstem Abutment System | USPTA3550M | Osstem Implant Co., Ltd. | NHA | 08809917077288 |
| Osstem Abutment System | TSMTB0410GTH | Osstem Implant Co., Ltd. | NHA | 08809917073822 |