Device product
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
Z-0743-2025
Product summary
- Event
- Event 95828
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 171 orders
- Official record key
device-enforcement:Z-0743-2025
Official wording
Reason: Attachments may not mate with the tooth as intended in the digital treatment design.
Code information: Only 3M Clarity Precision Grip Attachment Dual Arch Attachments are potentially affected. Part numbers/UDI-DI: 359-830/ 00652221307286; 359-831/ 00652221307293; 359-832/00652221307309; 359-833/ 00652221307316; 359-834/ 00652221307361; 359-835/ 00652221307378; 359-836/ 00652221307385; 359-837/ 00652221307392
Distribution pattern: Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
Derived failure modes
-
Unknown
Attachments may not mate with the tooth as intended in the digital treatment design.