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

Clearance record K233194

TS Abutment System · Osstem Implant Co., Ltd. · decided 2024-02-20 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ET Multi Angled AbutmentETMA517SHWHIOSSEN, INC.NHA00810125999116
EK MULTI ANGLED ABUTMENTET30MUA485MWHHIOSSEN, INC.NHA00810126047052
EK MULTI ANGLED ABUTMENTET30MUA484RWHHIOSSEN, INC.NHA00810126047045
EK MULTI ANGLED ABUTMENTET30MUA484MWHHIOSSEN, INC.NHA00810126047038
EK MULTI ANGLED ABUTMENTET30MUA483RWHHIOSSEN, INC.NHA00810126047021
EK MULTI ANGLED ABUTMENTET30MUA483MWHHIOSSEN, INC.NHA00810126047014
EK MULTI ANGLED ABUTMENTET17MUA485RWHHIOSSEN, INC.NHA00810126047007
EK MULTI ANGLED ABUTMENTET17MUA484MWHHIOSSEN, INC.NHA00810126046987
EK MULTI ANGLED ABUTMENTET17MUA482RWHHIOSSEN, INC.NHA00810126046956
EK MULTI ANGLED ABUTMENTET30MUA485RWHHIOSSEN, INC.NHA00810126047069
EK MULTI ANGLED ABUTMENTET17MUA484RWHHIOSSEN, INC.NHA00810126046994
EK MULTI ANGLED ABUTMENTET17MUA483RWHHIOSSEN, INC.NHA00810126046970
EK MULTI ANGLED ABUTMENTET17MUA483MWHHIOSSEN, INC.NHA00810126046963
EK MULTI ANGLED ABUTMENTET17MUA482MWHHIOSSEN, INC.NHA00810126046949