Device product

Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

Z-1100-2022

March 18, 2022

Class II

Product summary

Firm: Clinician's Choice Dental Products Inc.
Event: Event 90031
Status: Terminated
Classification: Class II
Quantity: 46 units
Official record key: device-enforcement:Z-1100-2022

Official wording

Reason: Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

Code information: LOT No.: 611612 (UDI): 07540172000178

Distribution pattern: Distributed in SC.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK