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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K200817

URIS OMNI Narrow System & Prosthetic · Truabutment, Inc. · decided 2020-10-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Multi-Unit Angled AbutmentU30MUAN5050HTruabutment Korea Co.,LtdNHA08800076443709
Ball AbutmentUBA3530Truabutment Korea Co.,LtdNHA08800076404540
OMNI Tapered FixtureNTF30145Truabutment Korea Co.,LtdDZE08800076400443
URIS BaseUBN4023NATruabutment Korea Co.,LtdNHA08800076431591
Ball AbutmentUBA3520Truabutment Korea Co.,LtdNHA08800076404533
Ball AbutmentUBA3510Truabutment Korea Co.,LtdNHA08800076404526
Multi-Unit Angled AbutmentU17MUAN5040HTruabutment Korea Co.,LtdNHA08800076443679
URIS BaseUBN4015HATruabutment Korea Co.,LtdNHA08800076405035
OMNI Tapered FixtureNTF30115Truabutment Korea Co.,LtdDZE08800076400429
URIS BaseUBN4038HSTruabutment Korea Co.,LtdNHA08800076405134
OMNI Straight FixtureOMF30100Truabutment Korea Co.,LtdDZE08800076400016
URIS BaseUBR4315NATruabutment Korea Co.,LtdNHA08800076405097
T LOC Straight AbutmentUTLAN3850Truabutment Korea Co.,LtdNHA08800076443822
Multi-Unit Ti CylinderUMTIC50NTruabutment Korea Co.,LtdNHA08800076404854
URIS BaseUBR4323HATruabutment Korea Co.,LtdNHA08800076431614
OMNI Straight FixtureOMF30145Truabutment Korea Co.,LtdDZE08800076400047
Multi-Unit Straight AbutmentUMA5030Truabutment Korea Co.,LtdNHA08800076404687
Ball AbutmentUBAN3530Truabutment Korea Co.,LtdNHA08800076404489
Multi-Unit Angled AbutmentU30MUAN5060HTruabutment Korea Co.,LtdNHA08800076443716
Multi-Unit Angled AbutmentU17MUAN5030HTruabutment Korea Co.,LtdNHA08800076443662
URIS BaseUBR4538HSTruabutment Korea Co.,LtdNHA08800076405172
Multi-Unit Straight AbutmentUMAN5060Truabutment Korea Co.,LtdNHA08800076404656
Multi-Unit Angled AbutmentU30MUAR5060HTruabutment Korea Co.,LtdNHA08800076443778
URIS BaseUBR4315HATruabutment Korea Co.,LtdNHA08800076405073
Multi-Unit Cylinder ScrewUMCS16Truabutment Korea Co.,LtdNHA08800076404892