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Zirconia Dental Ceramics

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref BSM-D98×30 STML B3Ref BSM-D98×22 HT+Ref BSM-D98×14 ST Preshade B3Ref BSM-D98×18 TTML C2Ref BSM-D98×10 ST Preshade B3Ref BSM-D98×28 STML C1Ref BSM-D98×25 STML A4Ref BSM-D98×18 STML B1Ref BSM-D98×14 ST Preshade D3Ref BSM-D98×10 ST Preshade A3Ref BSM-D98×18 TTML A2Ref BSM-D98×18 STML B4Ref BSM-D98×22 TTRef BSM-D98×14 HT+Ref BSM-D98×16 STML 0M1Ref BSM-D98×30 TTML C3Ref BSM-D98×25 TTML D3Ref BSM-D98×16 ST Preshade D4Ref BSM-D98×22 TTML 0M1Ref BSM-D98×10 STML C3Ref BSM-D98×20 TTML 0M3Ref BSM-D98×16 ST Preshade A3.5Ref BSM-D98×12 ST Preshade B2Ref BSM-D98×18 STML C2Ref BSM-D98×18 TTRef BSM-D98×25 TTML C4Ref BSM-D98×28 STML B2Ref BSM-D98×14 STML B4Ref BSM-D98×22 STML A1Ref BSM-D98×22 TTML D2Ref BSM-D98×10 STML B1Ref BSM-D98×16 STML D2Ref BSM-D98×20 STML C1Ref BSM-D98×28 TTML C3Ref BSM-D98×20 TTML D2Ref BSM-D98×22 TTML D3Ref BSM-D98×20 STML B3Ref BSM-D98×28 STML D2Ref BSM-D98×18 STML C4Ref BSM-D98×30 TTML B4Ref BSM-D98×25 STML B2Ref BSM-D98×25 STML A1Ref BSM-D98×22 TTML C2Ref BSM-D98×28 TTML C1Ref BSM-D98×10 ST Preshade A2Ref BSM-D98×12 HT+Ref BSM-D98×20 TTML 0M2Ref BSM-D98×20 TTML D4Ref BSM-D98×10 STML B4Ref BSM-D98×18 TTML A1Ref BSM-D98×20 TTML C1Ref BSM-D98×30 STRef BSM-D98×30 TTML 0M3Ref BSM-D98×10 ST Preshade A4Ref BSM-D98×22 TTML B1Ref BSM-D98×16 STML C1Ref BSM-D98×22 TTML B3Ref BSM-D98×22 STML 0M2Ref BSM-D98×30 SHTRef BSM-D98×18 TTML D4Ref BSM-D98×10 TTRef BSM-D98×14 ST Preshade 0M2Ref BSM-D98×14 STML 0M2Ref BSM-D98×18 STML A2Ref BSM-D98×12 STML A4Ref BSM-D98×16 ST Preshade B2Ref BSM-D98×12 ST Preshade A1Ref BSM-D98×14 STML A3Ref BSM-D98×12 STML 0M3Ref BSM-D98×16 STML C2Ref BSM-D98×20 TTML A1Ref BSM-D98×16 STML 0M3Ref BSM-D98×10 STML B2Ref BSM-D98×30 TTML C1Ref BSM-D98×30 STML B2Ref BSM-D98×14 STML A3.5Ref BSM-D98×28 STML C3Ref BSM-D98×20 TTML C3Ref BSM-D98×14 ST Preshade C2Ref BSM-D98×16 ST Preshade B1Ref BSM-D98×25 TTML B3Ref BSM-D98×16 SHTRef BSM-D98×20 TTML B1Ref BSM-D98×28 TTML D4Ref BSM-D98×12 SHTRef BSM-D98×18 STML D3Ref BSM-D98×16 ST Preshade A2Ref BSM-D98×22 STML C4Ref BSM-D98×12 ST Preshade 0M3Ref BSM-D98×12 STML C4Ref BSM-D98×22 STML B2Ref BSM-D98×25 HT+Ref BSM-D98×14 STML D3Ref BSM-D98×30 TTML 0M2Ref BSM-D98×18 TTML C3Ref BSM-D98×28 STML C4Ref BSM-D98×28 TTML B4Ref BSM-D98×20 STML A3Ref BSM-D98×28 STML C2Ref BSM-D98×20 STML A3.5Ref BSM-D98×16 STML B1Ref BSM-D98×25 TTML D2Ref BSM-D98×10 ST Preshade 0M1Ref BSM-D98×12 STML D4Ref BSM-D98×30 STML 0M1Ref BSM-D98×25 TTML A2Ref BSM-D98×30 STML A1Ref BSM-D98×14 STML C3Ref BSM-D98×28 STML B1Ref BSM-D98×25 STML D2Ref BSM-D98×28 TTML D2Ref BSM-D98×10 ST Preshade 0M2Ref BSM-D98×25 STML D4Ref BSM-D98×28 STML A1Ref BSM-D98×30 STML C3Ref BSM-D98×25 STML D3Ref BSM-D98×20 STML D2Ref BSM-D98×30 STML C4Ref BSM-D98×28 TTML 0M2Ref BSM-D98×25 TTML C3Ref BSM-D98×18 STML A1Ref BSM-D98×18 STML 0M1Ref BSM-D98×16 ST Preshade C1Ref BSM-D98×25 STML A3Ref BSM-D98×18 TTML B1Ref BSM-D98×30 STML C1Ref BSM-D98×28 STML A3.5Ref BSM-D98×20 STML C4Ref BSM-D98×25 STML 0M3Ref BSM-D98×10 STML 0M1Ref BSM-D98×18 TTML A4Ref BSM-D98×16 STML A3.5Ref BSM-D98×14 STML A2Ref BSM-D98×12 STML C3Ref BSM-D98×28 TTML A4Ref BSM-D98×28 TTML B2Ref BSM-D98×28 HT+Ref BSM-D98×30 TTML A4Ref BSM-D98×25 STML C2Ref BSM-D98×22 TTML C1Ref BSM-D98×25 STML C1Ref BSM-D98×30 TTML A3.5Ref BSM-D98×30 STML C2Ref BSM-D98×25 STML C3Ref BSM-D98×20 TTML B3Ref BSM-D98×20 TTML B4Ref BSM-D98×22 STML B1Ref BSM-D98×28 TTRef BSM-D98×30 TTML A1Ref BSM-D98×16 TTRef BSM-D98×28 TTML A1Ref BSM-D98×12 STML B2Ref BSM-D98×12 ST Preshade A3.5Ref BSM-D98×30 TTML D4Ref BSM-D98×28 TTML B1Ref BSM-D98×12 STML 0M1Ref BSM-D98×10 STML 0M3Ref BSM-D98×20 STML A2Ref BSM-D98×12 STML B3Ref BSM-D98×10 STML 0M2Ref BSM-D98×30 TTML A3Ref BSM-D98×28 STML D3Ref BSM-D98×18 TTML 0M1Ref BSM-D98×18 STML 0M2Ref BSM-D98×28 TTML A3Ref BSM-D98×10 STML C1Ref BSM-D98×16 STML A2Ref BSM-D98×28 STML 0M1Ref BSM-D98×30 STML 0M3Ref BSM-D98×30 STML A2Ref BSM-D98×10 STML A1Ref BSM-D98×22 TTML A4Ref BSM-D98×20 STML C2Ref BSM-D98×14 STML B2Ref BSM-D98×28 TTML A2Ref BSM-D98×12 STML A3.5Ref BSM-D98×28 TTML D3Ref BSM-D98×14 STML B1Ref BSM-D98×18 TTML C1Ref BSM-D98×18 STML D2Ref BSM-D98×30 TTML D2Ref BSM-D98×10 STML B3Ref BSM-D98×10 SHTRef BSM-D98×18 STML 0M3Ref BSM-D98×18 STML B3Ref BSM-D98×22 STML 0M1Ref BSM-D98×12 STML B1Ref BSM-D98×30 STML B1Ref BSM-D98×18 TTML A3Ref BSM-D98×20 TTML A3Ref BSM-D98×12 STML D2Ref BSM-D98×20 STML A4Ref BSM-D98×28 STML B4Ref BSM-D98×22 TTML A3.5Ref BSM-D98×14 TTRef BSM-D98×22 TTML C4Ref BSM-D98×25 TTML A3Ref BSM-D98×10 STML D2Ref BSM-D98×30 STML 0M2Ref BSM-D98×12 TTRef BSM-D98×12 STML B4Ref BSM-D98×12 STML A3Ref BSM-D98×12 ST Preshade 0M1Ref BSM-D98×18 STML D4Ref BSM-D98×28 TTML C2Ref BSM-D98×22 TTML A1Ref BSM-D98×25 STML B1Ref BSM-D98×22 STML A3Ref BSM-D98×25 STML 0M2Ref BSM-D98×28 SHTRef BSM-D98×10 ST Preshade 0M3Ref BSM-D98×22 TTML B2Ref BSM-D98×12 STRef BSM-D98×30 TTML B2Ref BSM-D98×16 STML 0M2Ref BSM-D98×20 STML B1Ref BSM-D98×25 TTML B2Ref BSM-D98×22 STRef BSM-D98×10 ST Preshade B2Ref BSM-D98×14 ST Preshade A3Ref BSM-D98×10 STML C2Ref BSM-D98×10 STML A3Ref BSM-D98×16 ST Preshade A1Ref BSM-D98×18 TTML D2Ref BSM-D98×22 STML A3.5Ref BSM-D98×14 ST Preshade D4Ref BSM-D98×14 ST Preshade C3Ref BSM-D98×12 ST Preshade A4Ref BSM-D98×14 ST Preshade 0M3Ref BSM-D98×12 ST Preshade C4Ref BSM-D98×14 ST Preshade B1Ref BSM-D98×12 ST Preshade D2Ref BSM-D98×12 ST Preshade B1Ref BSM-D98×10 ST Preshade B4Ref BSM-D98×10 ST Preshade A3.5Ref BSM-D98×12 ST Preshade C1Ref BSM-D98×14 ST Preshade B2Ref BSM-D98×10 ST Preshade C1

by Chengdu Besmile Medical Technology Co., Ltd.

Identity

Trade Name
Zirconia Dental Ceramics EUDAMEDFDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
Zirconia Dental Ceramics EUDAMED
Model / Reference
BSM-D98×30 STML B3 EUDAMEDFDA UDI
BSM-D98×22 HT+ EUDAMEDFDA UDI
BSM-D98×14 ST Preshade B3 EUDAMED
BSM-D98×18 TTML C2 EUDAMEDFDA UDI
BSM-D98×10 ST Preshade B3 EUDAMEDFDA UDI
BSM-D98×28 STML C1 EUDAMEDFDA UDI
BSM-D98×25 STML A4 EUDAMEDFDA UDI
BSM-D98×18 STML B1 EUDAMEDFDA UDI
BSM-D98×14 ST Preshade D3 EUDAMED
BSM-D98×10 ST Preshade A3 EUDAMEDFDA UDI
BSM-D98×18 TTML A2 EUDAMEDFDA UDI
BSM-D98×18 STML B4 EUDAMEDFDA UDI
BSM-D98×22 TT EUDAMED
BSM-D98×14 HT+ EUDAMEDFDA UDI
BSM-D98×16 STML 0M1 EUDAMEDFDA UDI
BSM-D98×30 TTML C3 EUDAMED
BSM-D98×25 TTML D3 EUDAMEDFDA UDI
BSM-D98×16 ST Preshade D4 EUDAMED
BSM-D98×22 TTML 0M1 EUDAMEDFDA UDI
BSM-D98×10 STML C3 EUDAMED
BSM-D98×20 TTML 0M3 EUDAMED
BSM-D98×16 ST Preshade A3.5 EUDAMED
BSM-D98×12 ST Preshade B2 EUDAMED
BSM-D98×18 STML C2 EUDAMEDFDA UDI
BSM-D98×18 TT EUDAMED
BSM-D98×25 TTML C4 EUDAMEDFDA UDI
BSM-D98×28 STML B2 EUDAMEDFDA UDI
BSM-D98×14 STML B4 EUDAMEDFDA UDI
BSM-D98×22 STML A1 EUDAMEDFDA UDI
BSM-D98×22 TTML D2 EUDAMEDFDA UDI
BSM-D98×10 STML B1 EUDAMED
BSM-D98×16 STML D2 EUDAMEDFDA UDI
BSM-D98×20 STML C1 EUDAMEDFDA UDI
BSM-D98×28 TTML C3 EUDAMED
BSM-D98×20 TTML D2 EUDAMED
BSM-D98×22 TTML D3 EUDAMEDFDA UDI
BSM-D98×20 STML B3 EUDAMEDFDA UDI
BSM-D98×28 STML D2 EUDAMEDFDA UDI
BSM-D98×18 STML C4 EUDAMEDFDA UDI
BSM-D98×30 TTML B4 EUDAMED
BSM-D98×25 STML B2 EUDAMEDFDA UDI
BSM-D98×25 STML A1 EUDAMEDFDA UDI
BSM-D98×22 TTML C2 EUDAMEDFDA UDI
BSM-D98×28 TTML C1 EUDAMED
BSM-D98×10 ST Preshade A2 EUDAMEDFDA UDI
BSM-D98×12 HT+ EUDAMEDFDA UDI
BSM-D98×20 TTML 0M2 EUDAMED
BSM-D98×20 TTML D4 EUDAMED
BSM-D98×10 STML B4 EUDAMED
BSM-D98×18 TTML A1 EUDAMEDFDA UDI
BSM-D98×20 TTML C1 EUDAMED
BSM-D98×30 ST EUDAMEDFDA UDI
BSM-D98×30 TTML 0M3 EUDAMED
BSM-D98×10 ST Preshade A4 EUDAMEDFDA UDI
BSM-D98×22 TTML B1 EUDAMEDFDA UDI
BSM-D98×16 STML C1 EUDAMEDFDA UDI
BSM-D98×22 TTML B3 EUDAMEDFDA UDI
BSM-D98×22 STML 0M2 EUDAMEDFDA UDI
BSM-D98×30 SHT EUDAMEDFDA UDI
BSM-D98×18 TTML D4 EUDAMEDFDA UDI
BSM-D98×10 TT EUDAMED
BSM-D98×14 ST Preshade 0M2 EUDAMED
BSM-D98×14 STML 0M2 EUDAMEDFDA UDI
BSM-D98×18 STML A2 EUDAMEDFDA UDI
BSM-D98×12 STML A4 EUDAMEDFDA UDI
BSM-D98×16 ST Preshade B2 EUDAMED
BSM-D98×12 ST Preshade A1 EUDAMED
BSM-D98×14 STML A3 EUDAMEDFDA UDI
BSM-D98×12 STML 0M3 EUDAMEDFDA UDI
BSM-D98×16 STML C2 EUDAMEDFDA UDI
BSM-D98×20 TTML A1 EUDAMED
BSM-D98×16 STML 0M3 EUDAMEDFDA UDI
BSM-D98×10 STML B2 EUDAMED
BSM-D98×30 TTML C1 EUDAMED
BSM-D98×30 STML B2 EUDAMEDFDA UDI
BSM-D98×14 STML A3.5 EUDAMEDFDA UDI
BSM-D98×28 STML C3 EUDAMEDFDA UDI
BSM-D98×20 TTML C3 EUDAMED
BSM-D98×14 ST Preshade C2 EUDAMED
BSM-D98×16 ST Preshade B1 EUDAMED
BSM-D98×25 TTML B3 EUDAMEDFDA UDI
BSM-D98×16 SHT EUDAMEDFDA UDI
BSM-D98×20 TTML B1 EUDAMED
BSM-D98×28 TTML D4 EUDAMED
BSM-D98×12 SHT EUDAMEDFDA UDI
BSM-D98×18 STML D3 EUDAMEDFDA UDI
BSM-D98×16 ST Preshade A2 EUDAMED
BSM-D98×22 STML C4 EUDAMEDFDA UDI
BSM-D98×12 ST Preshade 0M3 EUDAMED
BSM-D98×12 STML C4 EUDAMEDFDA UDI
BSM-D98×22 STML B2 EUDAMEDFDA UDI
BSM-D98×25 HT+ EUDAMEDFDA UDI
BSM-D98×14 STML D3 EUDAMEDFDA UDI
BSM-D98×30 TTML 0M2 EUDAMED
BSM-D98×18 TTML C3 EUDAMEDFDA UDI
BSM-D98×28 STML C4 EUDAMEDFDA UDI
BSM-D98×28 TTML B4 EUDAMED
BSM-D98×20 STML A3 EUDAMEDFDA UDI
BSM-D98×28 STML C2 EUDAMEDFDA UDI
BSM-D98×20 STML A3.5 EUDAMEDFDA UDI
BSM-D98×16 STML B1 EUDAMEDFDA UDI
BSM-D98×25 TTML D2 EUDAMEDFDA UDI
BSM-D98×10 ST Preshade 0M1 EUDAMED
BSM-D98×12 STML D4 EUDAMEDFDA UDI
BSM-D98×30 STML 0M1 EUDAMEDFDA UDI
BSM-D98×25 TTML A2 EUDAMEDFDA UDI
BSM-D98×30 STML A1 EUDAMEDFDA UDI
BSM-D98×14 STML C3 EUDAMEDFDA UDI
BSM-D98×28 STML B1 EUDAMEDFDA UDI
BSM-D98×25 STML D2 EUDAMEDFDA UDI
BSM-D98×28 TTML D2 EUDAMED
BSM-D98×10 ST Preshade 0M2 EUDAMED
BSM-D98×25 STML D4 EUDAMEDFDA UDI
BSM-D98×28 STML A1 EUDAMEDFDA UDI
BSM-D98×30 STML C3 EUDAMEDFDA UDI
BSM-D98×25 STML D3 EUDAMEDFDA UDI
BSM-D98×20 STML D2 EUDAMEDFDA UDI
BSM-D98×30 STML C4 EUDAMEDFDA UDI
BSM-D98×28 TTML 0M2 EUDAMED
BSM-D98×25 TTML C3 EUDAMEDFDA UDI
BSM-D98×18 STML A1 EUDAMEDFDA UDI
BSM-D98×18 STML 0M1 EUDAMEDFDA UDI
BSM-D98×16 ST Preshade C1 EUDAMED
BSM-D98×25 STML A3 EUDAMEDFDA UDI
BSM-D98×18 TTML B1 EUDAMEDFDA UDI
BSM-D98×30 STML C1 EUDAMEDFDA UDI
BSM-D98×28 STML A3.5 EUDAMEDFDA UDI
BSM-D98×20 STML C4 EUDAMEDFDA UDI
BSM-D98×25 STML 0M3 EUDAMEDFDA UDI
BSM-D98×10 STML 0M1 EUDAMEDFDA UDI
BSM-D98×18 TTML A4 EUDAMEDFDA UDI
BSM-D98×16 STML A3.5 EUDAMEDFDA UDI
BSM-D98×14 STML A2 EUDAMEDFDA UDI
BSM-D98×12 STML C3 EUDAMEDFDA UDI
BSM-D98×28 TTML A4 EUDAMED
BSM-D98×28 TTML B2 EUDAMED
BSM-D98×28 HT+ EUDAMEDFDA UDI
BSM-D98×30 TTML A4 EUDAMED
BSM-D98×25 STML C2 EUDAMEDFDA UDI
BSM-D98×22 TTML C1 EUDAMEDFDA UDI
BSM-D98×25 STML C1 EUDAMEDFDA UDI
BSM-D98×30 TTML A3.5 EUDAMED
BSM-D98×30 STML C2 EUDAMEDFDA UDI
BSM-D98×25 STML C3 EUDAMEDFDA UDI
BSM-D98×20 TTML B3 EUDAMED
BSM-D98×20 TTML B4 EUDAMED
BSM-D98×22 STML B1 EUDAMEDFDA UDI
BSM-D98×28 TT EUDAMED
BSM-D98×30 TTML A1 EUDAMED
BSM-D98×16 TT EUDAMEDFDA UDI
BSM-D98×28 TTML A1 EUDAMED
BSM-D98×12 STML B2 EUDAMEDFDA UDI
BSM-D98×12 ST Preshade A3.5 EUDAMED
BSM-D98×30 TTML D4 EUDAMED
BSM-D98×28 TTML B1 EUDAMED
BSM-D98×12 STML 0M1 EUDAMEDFDA UDI
BSM-D98×10 STML 0M3 EUDAMEDFDA UDI
BSM-D98×20 STML A2 EUDAMEDFDA UDI
BSM-D98×12 STML B3 EUDAMEDFDA UDI
BSM-D98×10 STML 0M2 EUDAMEDFDA UDI
BSM-D98×30 TTML A3 EUDAMED
BSM-D98×28 STML D3 EUDAMEDFDA UDI
BSM-D98×18 TTML 0M1 EUDAMED
BSM-D98×18 STML 0M2 EUDAMEDFDA UDI
BSM-D98×28 TTML A3 EUDAMED
BSM-D98×10 STML C1 EUDAMED
BSM-D98×16 STML A2 EUDAMEDFDA UDI
BSM-D98×28 STML 0M1 EUDAMEDFDA UDI
BSM-D98×30 STML 0M3 EUDAMEDFDA UDI
BSM-D98×30 STML A2 EUDAMEDFDA UDI
BSM-D98×10 STML A1 EUDAMED
BSM-D98×22 TTML A4 EUDAMEDFDA UDI
BSM-D98×20 STML C2 EUDAMEDFDA UDI
BSM-D98×14 STML B2 EUDAMEDFDA UDI
BSM-D98×28 TTML A2 EUDAMED
BSM-D98×12 STML A3.5 EUDAMEDFDA UDI
BSM-D98×28 TTML D3 EUDAMED
BSM-D98×14 STML B1 EUDAMEDFDA UDI
BSM-D98×18 TTML C1 EUDAMEDFDA UDI
BSM-D98×18 STML D2 EUDAMEDFDA UDI
BSM-D98×30 TTML D2 EUDAMED
BSM-D98×10 STML B3 EUDAMED
BSM-D98×10 SHT EUDAMEDFDA UDI
BSM-D98×18 STML 0M3 EUDAMEDFDA UDI
BSM-D98×18 STML B3 EUDAMEDFDA UDI
BSM-D98×22 STML 0M1 EUDAMEDFDA UDI
BSM-D98×12 STML B1 EUDAMEDFDA UDI
BSM-D98×30 STML B1 EUDAMEDFDA UDI
BSM-D98×18 TTML A3 EUDAMEDFDA UDI
BSM-D98×20 TTML A3 EUDAMED
BSM-D98×12 STML D2 EUDAMEDFDA UDI
BSM-D98×20 STML A4 EUDAMEDFDA UDI
BSM-D98×28 STML B4 EUDAMEDFDA UDI
BSM-D98×22 TTML A3.5 EUDAMEDFDA UDI
BSM-D98×14 TT EUDAMED
BSM-D98×22 TTML C4 EUDAMEDFDA UDI
BSM-D98×25 TTML A3 EUDAMEDFDA UDI
BSM-D98×10 STML D2 EUDAMED
BSM-D98×30 STML 0M2 EUDAMEDFDA UDI
BSM-D98×12 TT EUDAMED
BSM-D98×12 STML B4 EUDAMEDFDA UDI
BSM-D98×12 STML A3 EUDAMEDFDA UDI
BSM-D98×12 ST Preshade 0M1 EUDAMED
BSM-D98×18 STML D4 EUDAMEDFDA UDI
BSM-D98×28 TTML C2 EUDAMED
BSM-D98×22 TTML A1 EUDAMEDFDA UDI
BSM-D98×25 STML B1 EUDAMEDFDA UDI
BSM-D98×22 STML A3 EUDAMEDFDA UDI
BSM-D98×25 STML 0M2 EUDAMEDFDA UDI
BSM-D98×28 SHT EUDAMEDFDA UDI
BSM-D98×10 ST Preshade 0M3 EUDAMED
BSM-D98×22 TTML B2 EUDAMEDFDA UDI
BSM-D98×12 ST EUDAMEDFDA UDI
BSM-D98×30 TTML B2 EUDAMED
BSM-D98×16 STML 0M2 EUDAMEDFDA UDI
BSM-D98×20 STML B1 EUDAMEDFDA UDI
BSM-D98×25 TTML B2 EUDAMEDFDA UDI
BSM-D98×22 ST EUDAMEDFDA UDI
BSM-D98×10 ST Preshade B2 EUDAMEDFDA UDI
BSM-D98×14 ST Preshade A3 EUDAMED
BSM-D98×10 STML C2 EUDAMED
BSM-D98×10 STML A3 EUDAMED
BSM-D98×16 ST Preshade A1 EUDAMED
BSM-D98×18 TTML D2 EUDAMEDFDA UDI
BSM-D98×22 STML A3.5 EUDAMEDFDA UDI
BSM-D98×14 ST Preshade D4 EUDAMED
BSM-D98×14 ST Preshade C3 EUDAMED
BSM-D98×12 ST Preshade A4 EUDAMED
BSM-D98×14 ST Preshade 0M3 EUDAMED
BSM-D98×12 ST Preshade C4 EUDAMED
BSM-D98×14 ST Preshade B1 EUDAMED
BSM-D98×12 ST Preshade D2 EUDAMED
BSM-D98×12 ST Preshade B1 EUDAMED
BSM-D98×10 ST Preshade B4 EUDAMEDFDA UDI
BSM-D98×10 ST Preshade A3.5 EUDAMEDFDA UDI
BSM-D98×12 ST Preshade C1 EUDAMED
BSM-D98×14 ST Preshade B2 EUDAMED
BSM-D98×10 ST Preshade C1 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06932195363346 EUDAMEDFDA UDI
06932195330225 EUDAMEDFDA UDI
06975581885350 EUDAMED
06932195312443 EUDAMEDFDA UDI
06975581884858 EUDAMEDFDA UDI
06932195362912 EUDAMEDFDA UDI
06932195318650 EUDAMEDFDA UDI
06932195318162 EUDAMEDFDA UDI
06975581885428 EUDAMED
06975581884803 EUDAMEDFDA UDI
06932195312351 EUDAMEDFDA UDI
06932195318193 EUDAMEDFDA UDI
06975581881444 EUDAMED
06932195330188 EUDAMEDFDA UDI
06932195318025 EUDAMEDFDA UDI
06932195356300 EUDAMED
06932195313235 EUDAMEDFDA UDI
06975581885688 EUDAMED
06932195313006 EUDAMEDFDA UDI
06932195317226 EUDAMED
06932195312771 EUDAMED
06975581885565 EUDAMED
06975581885091 EUDAMED
06932195318216 EUDAMEDFDA UDI
06975581881420 EUDAMED
06932195313211 EUDAMEDFDA UDI
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06932195312474 EUDAMEDFDA UDI
06932195362189 EUDAMEDFDA UDI
06975581885435 EUDAMED
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06975581884865 EUDAMEDFDA UDI
06975581884810 EUDAMEDFDA UDI
06975581885121 EUDAMED
06975581885343 EUDAMED
06975581884872 EUDAMEDFDA UDI
Basic UDI-DI
697558188CK0708K6 EUDAMED
510(k) Number
K170894 FDA UDI
FDA Product Code
EIH FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Zirconia Dental Ceramics by Chengdu Besmile Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Chengdu Besmile Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000025929
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (599)

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