Device product
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Z-2356-2026
Product summary
- Event
- Event 98823
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 113
- Official record key
device-enforcement:Z-2356-2026
Official wording
Reason: Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
Code information: UDI-DI: 00842271175373, Lot: YBDGLD
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, MO, MN, NY, FL, ID and the countries of AT, CZ, DE, EE, EG, FR, GR, ID, IT, KZ, RS, SE, SI, TZ, VN.
Derived failure modes
-
Unknown
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.