Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4015R28 | HIOSSEN, INC. | DZE | 00814913022857 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4010R28 | HIOSSEN, INC. | DZE | 00814913022796 |
| HS II Fixture Mini RBM Pre-Mounted | AHS2M3511R18 | HIOSSEN, INC. | DZE | 00814913022697 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4513R18 | HIOSSEN, INC. | DZE | 00814913022932 |
| HS II Fixture Wide RBM Pre-Mounted | AHS2W5010R20 | HIOSSEN, INC. | DZE | 00814913023168 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4515R28 | HIOSSEN, INC. | DZE | 00814913022963 |
| HS II Fixture Wide RBM Pre-Mounted | AHS2W4508R20 | HIOSSEN, INC. | DZE | 00814913023090 |
| HS II Fixture Wide RBM Pre-Mounted | AHS2W5011R20 | HIOSSEN, INC. | DZE | 00814913023175 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R5010R28 | HIOSSEN, INC. | DZE | 00814913023014 |
| HUII/HSII Fixture System | HUCS35M | Osstem Implant Co., Ltd. | NHA | 08800000900049 |
| HUII/HSII Fixture System | HUCS50P | Osstem Implant Co., Ltd. | NHA | 08800000900025 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4510R18 | HIOSSEN, INC. | DZE | 00814913022895 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4010R18 | HIOSSEN, INC. | DZE | 00814913022789 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R5008R28 | HIOSSEN, INC. | DZE | 00814913022994 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4008R18 | HIOSSEN, INC. | DZE | 00814913022765 |
| HS II Fixture Wide RBM Pre-Mounted | AHS2W4510R20 | HIOSSEN, INC. | DZE | 00814913023106 |
| HUII/HSII Fixture System | HUCS41R | Osstem Implant Co., Ltd. | NHA | 08800000900032 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4007R18 | HIOSSEN, INC. | DZE | 00814913022758 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4513R28 | HIOSSEN, INC. | DZE | 00814913022949 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4511R28 | HIOSSEN, INC. | DZE | 00814913022925 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R5007R18 | HIOSSEN, INC. | DZE | 00814913022970 |
| HS II Fixture Wide RBM Pre-Mounted | AHS2W5013R20 | HIOSSEN, INC. | DZE | 00814913023182 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R4011R28 | HIOSSEN, INC. | DZE | 00814913022819 |
| HS II Fixture Regular RBM Pre-Mounted | AHS2R5011R28 | HIOSSEN, INC. | DZE | 00814913023038 |
| HS II Fixture Wide RBM Pre-Mounted | AHS2W4515R20 | HIOSSEN, INC. | DZE | 00814913023137 |