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2023年11月1日，西捷美公司更改了欧洲地区授权代表。新的授权代表为DSSM AG (地址: Im alten Riet 9, 9494 沙恩, 列支敦士登首都, 邮箱: contact@dssm.group).

自 2025 年 2 月 17 日起，DSSM AG 也将作为 Sagemax 设备新的法定制造商。在过渡期内，Sagemax Bioceramics Inc. 的产品仍可继续使用。包装上黑色工厂标识旁标注有相应的法定制造商信息。在下载专区，可通过查看参考文件名末尾字段来区分与两个法定制造商相关的文件版本。点击下方单独的按钮，即可访问 DSSM AG 和 Sagemax Bioceramics Inc. 的医疗器械电子使用说明 (E-IfU) 门户。

使用说明

MDR INSTRUCTIONS FOR USE
– DSSM AG

MDR INSTRUCTIONS FOR USE
– Sagemax Bioceramics Inc.

MDD INSTRUCTIONS FOR USE
– Sagemax Bioceramics Inc.

技術信息

Sintering Parameters for Programat S1, S1 1600 & S2
– Sagemax Bioceramics Inc.

Zirconia Preparation Guideline
– Sagemax Bioceramics Inc.

Sintering Parameters for Nabertherm
– Sagemax Bioceramics Inc.

NexxZr Zirconia Information Card
– Sagemax Bioceramics Inc.

Sintering Parameters for Shenpaz
– Sagemax Bioceramics Inc.

NexxZr T Multi Information Card
– Sagemax Bioceramics Inc.

Sintering Parameters for Zubler
– Sagemax Bioceramics Inc.

NexxZr+ Multi 2.0 Information Card
– Sagemax Bioceramics Inc.

Sintering Programs (XML-Files) for Nabertherm
– Sagemax Bioceramics Inc.

NexxZr+ Multi Information Card
– Sagemax Bioceramics Inc.

Sagemax Factor Converter

產品傳單

NexxZr T Multi vs NexxZr+ Multi 2.0
– Sagemax Bioceramics Inc.

NexxZr Tool D
– Sagemax Bioceramics Inc.

NexxZr+ Multi 2.0
– Sagemax Bioceramics Inc.

NexxZr Tool U
– Sagemax Bioceramics Inc.

NexxZr T Multi
– Sagemax Bioceramics Inc.

Wax Disc
– Sagemax Bioceramics Inc.

NexxZr T
– Sagemax Bioceramics Inc.

NexxZr Shine
– Sagemax Bioceramics Inc.

PressCeramic
– Sagemax Bioceramics Inc.

NexxZr T Multi & NexxZr+ Multi
– Sagemax Bioceramics Inc.

NexxZr+ Multi
– Sagemax Bioceramics Inc.

NexxZr+
– Sagemax Bioceramics Inc.

NexxZr S
– Sagemax Bioceramics Inc.

產品組合概覽

NexxZr Tool
– Sagemax Bioceramics Inc.

NexxZr Zirconia Portfolio
– Sagemax Bioceramics Inc.

安全數據表單

MDR NexxZr T, NexxZr T Multi
– Sagemax Bioceramics Inc.

MDR NexxZr+, NexxZr+ Multi
– Sagemax Bioceramics Inc.

MDR PressCeramic
– Sagemax Bioceramics Inc.

MDR NexxZr Zirconia & NexxZr+ Multi 2.0
– Sagemax Bioceramics Inc.

MDD NexxZr T Liquids A-D
– Sagemax Bioceramics Inc.

MDD NexxZr+ Coloring Liquids A1-B1
– Sagemax Bioceramics Inc.

MDD NexxZr+ Coloring Liquids A2,A3,A3.5,A4,B2,C1,C2,C3,C4,D2,D3,D4
– Sagemax Bioceramics Inc.

MDD NexxZr+ Coloring Liquids B3-B4
– Sagemax Bioceramics Inc.

MDD NexxZr Effect Liquid blue
– Sagemax Bioceramics Inc.

MDD NexxZr Effect Liquids brown
– Sagemax Bioceramics Inc.

MDD NexxZr Effect Liquid grey
– Sagemax Bioceramics Inc.

MDD NexxZr Effect Liquid incisal enhancer
– Sagemax Bioceramic Inc.

MDD NexxZr Effect Liquid violet
– Sagemax Bioceramics Inc.

MDD NexxZr+ Multi
– Sagemax Bioceramics Inc.

MDD NexxZr T Multi
– Sagemax Bioceramics Inc.

MDD NexxZr T/ + / S (Disc)
– Sagemax Bioceramics Inc.

MDD PMMA Disc
– Sagemax Bioceramics Inc.

MDD Wax Disc
– Sagemax Bioceramics Inc.

MDD PressCeramic
– Sagemax Bioceramics Inc.

MDD NexxZr Shine
– Sagemax Bioceramics Inc.

認證

EN ISO 13485:2016
– Sagemax Bioceramics Inc.

ISO 13485:2016 MDSAP
– Sagemax Bioceramics Inc.

KGMP
– Sagemax Bioceramics Inc.

EU Quality Management System (MDR)
– Sagemax Bioceramics Inc.

ISO 13485 MDSAP
– DSSM AG

EN ISO 13485
– DSSM AG

符合性聲明

NexxZr+ & NexxZr+ Multi
– Sagemax Bioceramics Inc.

NexxZr T & NexxZr T Multi
– Sagemax Bioceramics Inc.

NexxZr+ Multi 2.0
– Sagemax Bioceramics Inc.

PressCeramic
– Sagemax Bioceramics Inc.

CAD 材料參數