Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K140934
HIOSSEN IMPLANT SYSTEM · Hiossen, Inc. · decided 2014-11-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ET III Fixture SA Regular [ Implant Only] | ET3R4010S | HIOSSEN, INC. | DZE | 00814913029818 |
| ET III Fixture SA Regular No Mount | CET3R5007S | HIOSSEN, INC. | DZE | 00814913021133 |
| ET3 D5.5 SA Pre-mounted | AET3R5508S | HIOSSEN, INC. | DZE | 00810126043900 |
| ET Healing Abutment | ETHLA4003R | HIOSSEN, INC. | NHA | 00814913023212 |
| ET III SA Ultra-Wide Fixture Pre-Mounted | AET3R6008S | HIOSSEN, INC. | DZE | 00814913020860 |
| ET III SA Ultra-Wide Fixture No Mount | CET3R7006S | HIOSSEN, INC. | DZE | 00814913024912 |
| ET III Fixture SA Mini No Mount | CET3M3510S | HIOSSEN, INC. | DZE | 00814913020976 |
| ET III Fixture SA Regular [ Implant Only] | ET3R4008S | HIOSSEN, INC. | DZE | 00814913029801 |
| ET3 D5.5 SA Pre-mounted | AET3R5508S | HIOSSEN, INC. | DZE | 00814913029382 |
| ET III SA Ultra-Wide Fixture No Mount | CET3R7008S | HIOSSEN, INC. | DZE | 00810126045089 |
| ET II Fixture SA Mini No-Mounted | CET2M3515S | HIOSSEN, INC. | DZE | 00814913024554 |
| ET Healing Abutment | ETHLA6003R | HIOSSEN, INC. | NHA | 00814913023403 |
| ET cover screw Regular | ETCS40S-G | HIOSSEN, INC. | NHA | 00810126041609 |
| ET II Fixture SA Regular No-Mounted | CET2R4018S | HIOSSEN, INC. | DZE | 00814913024639 |
| ET III Fixture SA Regulsr Pre-Mounted | AET3R5006S | HIOSSEN, INC. | DZE | 00814913020761 |
| ET II Fixture SA Regular No-Mounted | CET2R5011S | HIOSSEN, INC. | DZE | 00814913024752 |
| ET III Fixture SA Mini [ Implant Only] | ET3M3515S | HIOSSEN, INC. | DZE | 00814913029788 |
| ET III SA Ultra-Wide Fixture Pre-Mounted | AET3R7011S | HIOSSEN, INC. | DZE | 00814913020945 |
| ET III Fixture SA Regular No Mount | CET3R4507S | HIOSSEN, INC. | DZE | 00810126044549 |
| ET Healing Abutment Mini, 4.3(D), 6.0(H) | ETHLA4006M | HIOSSEN, INC. | NHA | 00810126041425 |
| ET Healing Abutment | ETHLA4505M | HIOSSEN, INC. | NHA | 00814913023328 |
| ET III SA Ultra-Wide Fixture Pre-Mounted | AET3R6010S | HIOSSEN, INC. | DZE | 00810126044044 |
| ET Healing Abutment Regular, 4.3(D), 6.0(H) | ETHLA4006R | HIOSSEN, INC. | NHA | 00810126041432 |
| ET Healing Abutment | ETHLA4504R | HIOSSEN, INC. | NHA | 00814913023311 |
| ET II Fixture SA Regular Pre-Mounted | AET2R4513S | HIOSSEN, INC. | DZE | 00814913020402 |