Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K230438
URIS Smart Path Implant System & Prosthetic · Truabutment, Inc. · decided 2023-12-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SP Multi-Unit Angled Abutment | P30MAAWC5050 | Truabutment Korea Co.,Ltd | NHA | 08800076445604 |
| SP Multi-Unit Angled Abutment | P17MAAWC5030 | Truabutment Korea Co.,Ltd | NHA | 08800076445567 |
| SP Multi-Unit Straight Abutment | PMSANC5040 | Truabutment Korea Co.,Ltd | NHA | 08800076445291 |
| URIS SP Base | PBANC3825N | Truabutment Korea Co.,Ltd | NHA | 08800076445901 |
| URIS SP Base | PBANC3813 | Truabutment Korea Co.,Ltd | NHA | 08800076445802 |
| SP Healing Abutment | PHARC4550 | Truabutment Korea Co.,Ltd | NHA | 08800076444904 |
| SP Healing Abutment | PHARC6040 | Truabutment Korea Co.,Ltd | NHA | 08800076445017 |
| SP Healing Abutment | PHANC4010 | Truabutment Korea Co.,Ltd | NHA | 08800076444744 |
| SP Multi-Unit Straight Abutment | PMSAWC5060 | Truabutment Korea Co.,Ltd | NHA | 08800076445437 |
| SP Healing Abutment | PHAWC5050 | Truabutment Korea Co.,Ltd | NHA | 08800076445086 |
| SP Healing Abutment | PHANC5030 | Truabutment Korea Co.,Ltd | NHA | 08800076444829 |
| SP Healing Abutment | PHARC5060 | Truabutment Korea Co.,Ltd | NHA | 08800076444973 |
| Smart Path OMNI Thread Fixture | SPOT40145 | Truabutment Korea Co.,Ltd | DZE | 08800076444164 |
| URIS SP Base | PBANC3815 | Truabutment Korea Co.,Ltd | NHA | 08800076445833 |
| SP Healing Abutment | PHAWC5030 | Truabutment Korea Co.,Ltd | NHA | 08800076445062 |
| Smart Path OMNI Thread Fixture | SPOT40115 | Truabutment Korea Co.,Ltd | DZE | 08800076444140 |
| URIS SP Base | PBARC4313 | Truabutment Korea Co.,Ltd | NHA | 08800076445925 |
| SP Healing Abutment | PHANC5040 | Truabutment Korea Co.,Ltd | NHA | 08800076444836 |
| SP Healing Abutment | PHARC6050 | Truabutment Korea Co.,Ltd | NHA | 08800076445024 |
| SP Healing Abutment | PHAWC5060 | Truabutment Korea Co.,Ltd | NHA | 08800076445093 |
| Smart Path extra aggressive Thread Fixture | SPXT4549085 | Truabutment Korea Co.,Ltd | DZE | 08800076444546 |
| SP Multi-Unit Angled Abutment | P17MAANC5040 | Truabutment Korea Co.,Ltd | NHA | 08800076445451 |
| URIS SP Base | PBARC4810S | Truabutment Korea Co.,Ltd | NHA | 08800076446205 |
| SP Multi-Unit Straight Abutment | PMSARC5030 | Truabutment Korea Co.,Ltd | NHA | 08800076445345 |
| SP Healing Abutment | PHARC6030 | Truabutment Korea Co.,Ltd | NHA | 08800076445000 |