Device product
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
Z-2336-2021
Product summary
- Event
- Event 88427
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2336-2021
Official wording
Reason: Product label intended for the European community was distributed to the USA market via their US distribution organization
Code information: Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U
Distribution pattern: US Nationwide distribution in the state of TX.
Derived failure modes
-
Unknown
Product label intended for the European community was distributed to the USA market via their US distribution organization