International safety notice
Common names: (1)-(4) Dental laboratory-based computer-aided design and manufacturing unit (5) Dental resin model Materials (6) Resin for dental impression trays (7) Dental implant surgical instruments (8) Dental pattern resin (9) Dental occlusal recording Need to use materials Sales name: (1) Shining3D Auto Scanner EX Pro (2) Shining3D Auto Scanner EX (3) Shining3D auto scanner DS-MIX (4) AccuFab-L4D 3D printer (5) Shining3D model resin (6) Shining3D TR tray resin (7) Shining3D SG Surgical Guide Resin (8) Shining3D DC cast resin (9)Shining3D OD orthodontic resin
Japan / PMDA Recalls · JPN · Jan 16, 2023
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common names: (1)-(4) Dental laboratory-based computer-aided design and manufacturing unit (5) Dental resin model Materials (6) Resin for dental impression trays (7) Dental implant surgical instruments (8) Dental pattern resin (9) Dental occlusal recording Need to use materials Sales name: (1) Shining3D Auto Scanner EX Pro (2) Shining3D Auto Scanner EX (3) Shining3D auto scanner DS-MIX (4) AccuFab-L4D 3D printer (5) Shining3D model resin (6) Shining3D TR tray resin (7) Shining3D SG Surgical Guide Resin (8) Shining3D DC cast resin (9)Shining3D OD orthodontic resin |
| Manufacturer | Japan Quality Co., Ltd. |
| Models | AutoscanEPSA-BX002B26, AutoscanEPSA-AJ076F14, AutoscanEB-0AH147E14, 20211207-04, 20220913C05, AutoscanEPSA-AJ057K28, 20220527-02, AutoscanMIXB-BA046D13, AutoscanEPBA-AJ010C11, AutoscanEPSA-AJ021M03, AutoscanEPSA-AJ079K03, AutoscanEPSA-BX003B26 and 181 more |
| Date | Jan 16, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1