STT Tên trang thiết bị y tế Chủng loại/mã sản phẩm Hãng/nước sản xuất Hãng/nước chủ sở hữu Mục đích sử dụng theo chỉ định của chủ sở hữu Căn cứ để phân loại mức độ rủi ro Mức độ rủi ro được phân loại
1 Phôi cắt sườn răng giả Ceramill ZI Preforms (12 Stck./pcs.) Ceramill ZI Preforms L (12 Stck./pcs.) Ceramill ZI TC L (12 Stck./pcs.) Ceramill ZI 31 (6 Stck./pcs.) Ceramill ZI 51 L (3 Stck./pcs.) Ceramill ZI 71 XS (1 Stck./pcs.) Ceramill ZI 71 (1 Stck./pcs.) Ceramill ZI 71 L (1 Stck./pcs.) Ceramill ZI 71 XL (1 Stck./pcs.) Ceramill ZI 71 S (1 Stck./pcs.) Ceramill ZI 71 M (1 Stck./pcs.) Ceramill ZI 77 L (1 Stck./pcs.) Ceramill ZI 77 XL (1 Stck./pcs.) Ceramill ZI 77 L f. Multi-x (1 Stck./pcs.) Ceramill ZI 77 XL f. Multi-x (1 Stck./pcs.) Ceramill ZI CAM 98x10 (1 Stck./pcs.) Ceramill ZI CAM 98x10 (8 Stck./pcs.) Ceramill ZI CAM 98x14 (1 Stck./pcs.) Ceramill ZI CAM 98x14 (8 Stck./pcs.) Ceramill ZI CAM 98x16 (1 Stck./pcs.) Ceramill ZI CAM 98x16 (8 Stck./pcs.) Ceramill ZI CAM 98x18 (1 Stck./pcs.) Ceramill ZI CAM 98x18 (8 Stck./pcs.) Ceramill ZI CAM 98x20 (1 Stck./pcs.) Ceramill ZI CAM 98x20 (8 Stck./pcs.) Ceramill ZI CAM 98x25 (1 Stck./pcs.) Ceramill ZI CAM 98x14 N (1 Stck./pcs.) Ceramill ZI CAM 98x14 N (8 Stck./pcs.) Ceramill ZI CAM 98x16 N (1 Stck./pcs.) Ceramill ZI CAM 98x16 N (8 Stck./pcs.) Ceramill ZI CAM 98x18 N (1 Stck./pcs.) Ceramill ZI CAM 98x18 N (8 Stck./pcs.) Ceramill ZI CAM 98x20 N (1 Stck./pcs.) Ceramill ZI CAM 98x20 N (8 Stck./pcs.) Ceramill ZI CAM 98x25 N (1 Stck./pcs.) Ceramill ZI CAM 98x14 R (1 Stck./pcs.) Ceramill ZI CAM 98x20 R (1 Stck./pcs.) Ceramill ZOLID 71 XS Ceramill ZOLID 71 S Ceramill ZOLID 71 Ceramill ZOLID 71 M Ceramill ZOLID 71 L Ceramill ZOLID 71 XL Ceramill Zolid 98x25 N Ceramill Zolid 98x20 N Ceramill Zolid 98x18 N Ceramill Zolid 98x16 N Ceramill Zolid 98x14 N Ceramill Zolid 98x12 N Ceramill Zolid 98x10 N Ceramil ZOLID fx 71 XS Ceramil ZOLID fx 71 S Ceramil ZOLID fx 71 Ceramil ZOLID fx 71 M Ceramil ZOLID fx 71 L Ceramil ZOLID fx 71 XL Ceramill Zolid fx 98x12 N Ceramill Zolid fx 98x14 N Ceramill Zolid fx 98x16 N Ceramill Zolid fx 98x18 N Ceramill Zolid fx 98x20 N Ceramill Zolid fx 98x25 N Ceramill ZOLID preshade 1 71 XS Ceramill ZOLID preshade 1 71 Ceramill ZOLID preshade 1 71 L Ceramill ZOLID preshade 2 71 XS Ceramill ZOLID preshade 2 71 Ceramill ZOLID preshade 2 71 L Ceramill ZOLID preshade 3 71 XS Ceramill ZOLID preshade 3 71 Ceramill ZOLID preshade 3 71 L Ceramill ZOLID presahde 0 71 XS Ceramill ZOLID presahde 0 71 Ceramill ZOLID presahde 0 71 L Ceramill ZOLID PS 0 98x12 N Ceramill ZOLID PS 0 98x16 N Ceramill ZOLID PS 0 98x20 N Ceramill ZOLID PS 1 98x12 N Ceramill ZOLID PS 1 98x16 N Ceramill ZOLID PS 1 98x20 N Ceramill ZOLID PS 2 98x12 N Ceramill ZOLID PS 2 98x16 N Ceramill ZOLID PS 2 98x20 N Ceramill ZOLID PS 3 98x12 N Ceramill ZOLID PS 3 98x16 N Ceramill ZOLID PS 3 98x20 N Ceramill Zolid fx PS bleach 71 S Ceramill Zolid fx PS bleach 71 (16mm) Ceramill Zolid fx PS bleach 71 L (14mm) Ceramill Zolid fx PS A light 71 S (16mm) Ceramill Zolid fx PS A light 71 (16mm) Ceramill Zolid fx PS A light 71 L (20mm) Ceramill Zolid fx PS A medium 71 S 14mm Ceramill Zolid fx PS A medium 71 16mm Ceramill Zolid fx PS A medium 71 L 20mm Ceramill Zolid fx PS B light 71 S 14mm Ceramill Zolid fx PS B light 71 16mm Ceramill Zolid fx PS B light 71 L 20mm Ceramill Zolid fx PS bleach 98x14 N Ceramill Zolid fx PS bleach 98x16 N Ceramill Zolid fx PS bleach 98x20 N Ceramill Zolid fx PS A light 98x14 N Ceramill Zolid fx PS A light 98x16 N Ceramill Zolid fx PS A light 98x20 N Ceramill Zolid fx PS A medium 98x14 N Ceramill Zolid fx PS A medium 98x16 N Ceramill Zolid fx PS A medium 98x20 N Ceramill Zolid fx PS B light 98x14 N Ceramill Zolid fx PS B light 98x16 N Ceramill Zolid fx PS B light 98x20 N Ceramill PMMA 71L Ceramill PMMA 71XS Ceramill TEMP light 71 XS 13mm Ceramill TEMP middle 71 XS 13mm Ceramill TEMP dark 71 XS 13mm Ceramill TEMP light 71 L 20mm Ceramill TEMP middle 71 L 20mm Ceramill TEMP dark 71 L 20mm Ceramill TEMP bleach 71 XS 13mm Ceramill TEMP bleach 71 L 20mm Ceramill TEMP light 98x14 N Ceramill TEMP middle 98x14 N Ceramill TEMP dark 98x14 N Ceramill TEMP light 98x20 N Ceramill TEMP middle 98x20 N Ceramill TEMP dark 98x20 N Ceramill TEMP bleach 98x14 N Ceramill TEMP bleach 98x20 N Ceramill TEMP Multilayer A1/A2 71 XS (13mm) Ceramill TEMP Multilayer A3 71 XS (13mm) Ceramill TEMP Multilayer B1/B2 71 XS (13mm) Ceramill TEMP Multilayer C2/C3 71 XS (13mm) Ceramill TEMP Multilayer A1/A2 71 L (20mm) Ceramill TEMP Multilayer A3 71 L (20mm) Ceramill TEMP Multilayer B1/B2 71 L (20mm) Ceramill TEMP Multilayer C2/C3 71 L (20mm) Ceramill TEMP Multilayer A1/A2 98X12 N Ceramill TEMP Multilayer A3 98X12 N Ceramill TEMP Multilayer B1/B2 98X12 N Ceramill TEMP Multilayer C2/C3 98X12 N Ceramill TEMP Multilayer A1/A2 98X20 N Ceramill TEMP Multilayer A3 98X20 N Ceramill TEMP Multilayer B1/B2 98X20 N Ceramill TEMP Multilayer C1/C2 98X20 N Ceramill Splintec Standard 71 XS (13mm) Ceramill Splintec Standard 71 L (20mm) Ceramill Splintec Standard 98X12 N Ceramill Splintec Standard 98X20 N Ceramill Sintron 71XXS Ceramill Sintron 71XS Ceramill Sintron 71S Ceramill Sintron 71 Ceramill Sintron 71M Ceramill Sintron 71L Ceramill Sintron 71XXS Ceramill Sintron 71XS Ceramill Sintron 71S Ceramill Sintron 71 Ceramill Sintron 71M Ceramill Sintron 71L Ceramill Sintron 98x25 N Ceramill Sintron 98x20 N Ceramill Sintron 98x18 N Ceramill Sintron 98x16 N Ceramill Sintron 98x14 N Ceramill Sintron 98x12 N Ceramill Sintron 98x10 N Ceramill Zolid FX ML 71 Starterkit consisting of: 761734, 761738, 761746, 761750 Ceramill Zolid FX ML 98 Starterkit consisting of: 761777, 761781, 761789, 761793 Ceramill Zolid fx ML 0/A1 71 (16mm) Ceramill Zolid fx ML 0/A1 71 L (20mm) Ceramill Zolid fx ML A2/A3 71 (16mm) Ceramill Zolid fx ML A2/A3 71 L (20mm) Ceramill Zolid fx ML 0/B1 71 (16mm) Ceramill Zolid fx ML 0/B1 71 L (20mm) Ceramill Zolid fx ML B2/B3 71 (16mm) Ceramill Zolid fx ML B2/B3 71 L (20mm) Ceramill Zolid fx ML 0/A1 98x16 N Ceramill Zolid fx ML 0/A1 98x20 N Ceramill Zolid fx ML A2/A3 98x16 N Ceramill Zolid fx ML A2/A3 98x20 N Ceramill Zolid fx ML 0/B1 98x16 N Ceramill Zolid fx ML 0/B1 98x20 N Ceramill Zolid fx ML B2/B3 98x16 N Ceramill Zolid fx ML B2/B3 98x20 N Amann Girrbach AG, Austria Amann Girrbach AG, Austria Làm phục hình răng giả trong nha khoa Quy tắc 8 mục 1 TTBYT Loại B
2 Bột sứ đắp răng giả Ceramill Stain & Glaze Kit update 19 teilig Ceramill Stain yellow (4g) Ceramill Stain orange (4g) Ceramill Stain blue (4g) Ceramill Stain grey (4g) Ceramill Stain white (4g) Ceramill Stain A (4g) Ceramill Stain B (4g) Ceramill Stain C (4g) Ceramill Stain D (4g) Ceramill Stain violett Ceramill Stain red Ceramill Stain gingiva Ceramill Stain brown Ceramill Stain eggshell Ceramill Stain bleach Ceramill Stain dark brown Ceramill Glaze (4g) Amann Girrbach AG, Austria Amann Girrbach AG, Austria Làm phục hình răng giả trong nha khoa Quy tắc 8 mục 1 TTBYT Loại B
3 Dung dịch quét màu phục hình răng giả Ceramill Stain & Glaze Working Liquid (25 ml) Ceramill Stain & Glaze Reflow Liquid (8 ml) Ceramill Liquid A1 Ceramill Liquid A2 Ceramill Liquid A3 Ceramill Liquid A3,5 Ceramill Liquid A4 Ceramill Liquid B1 Ceramill Liquid B2 Ceramill Liquid B3 Ceramill Liquid B4 Ceramill Liquid C1 Ceramill Liquid C2 Ceramill Liquid C3 Ceramill Liquid C4 Ceramill Liquid D2 Ceramill Liquid D3 Ceramill Liquid D4 Ceramill Dimmer Liquid Refill Ceramill Liquid Set update Ceramill Liquid complete set Ceramill Liquid CL1 Ceramill Liquid CL2 Ceramill Liquid CL3 Ceramill Liquid CL4 Ceramill Liquid CL OR Ceramill Liquid CL GR Ceramill Liquid RO new formula Ceramill Liquid GIN new formula Ceramill Liqiud VIO new formula Ceramill Liquid OR new formula Ceramill Liquid GR new formula Ceramill Liquid fx Set ( incl A2, A3, A3.5, B3, OR, GR, BL, VIO, Ceramill Liquid Brush Size 1, Ceramill Liquid Brush Size 3, Kunstoffpinzette 8 Farbedoschen, Kurzzeitmesser) Ceramill Liquid FX A1 Ceramill Liquid FX A2 Ceramill Liquid FX A3 Ceramill Liquid FX A3,5 Ceramill Liquid FX A4 Ceramill Liquid FX B1 Ceramill Liquid FX B2 Ceramill Liquid FX B3 Ceramill Liquid FX B4 Ceramill Liquid FX C1 Ceramill Liquid FX C2 Ceramill Liquid FX C3 Ceramill Liquid FX C4 Ceramill Liquid FX D2 Ceramill Liquid FX D3 Ceramill Liquid FX D4 Ceramill Liquid FX OR Ceramill Liquid FX GR Ceramill Liquid FX RO Ceramill Liquid FX GIN Ceramill Liquid FX VIO Ceramill Liquid FX BL Fasthetix Liquid Starter Amann Girrbach AG, Austria Amann Girrbach AG, Austria Làm phục hình răng giả trong nha khoa Quy tắc 8 mục 1 TTBYT Loại B
4 Bộ đầy đủ vật liệu làm phục hình răng giả Ceramil Motion Einsteiger set Ceramil ZOLID Starter kit Ceramil Sintron Starter kit for CM1 Ceramil Sintron Starter kit for CM2 Ceramill Zolid fx Starterkit Amann Girrbach AG, Austria Amann Girrbach AG, Austria Làm phục hình răng giả trong nha khoa Quy tắc 8 mục 1 TTBYT Loại B