Device product
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Z-1408-2025
Product summary
- Event
- Event 96394
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 77 units
- Official record key
device-enforcement:Z-1408-2025
Official wording
Reason: The hardness not meeting the material specification and may cause the diamond bur to bend.
Code information: SKU: 807016C; UDI-DI: 00348783000237; Lot Numbers: M0117646, M0120260, M0123294;
Distribution pattern: US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
Derived failure modes
-
Unknown
The hardness not meeting the material specification and may cause the diamond bur to bend.