Recall Z-1100-2022— Clinician's Choice Dental Products Inc.

Name: FDA recall Z-1100-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-18

Class II · Terminated

Class II FDA medical device recall by Clinician's Choice Dental Products Inc., initiated 2022-03-18, terminated 2024-03-19. It names one FDA 510(k) clearance: K053014. 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. 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.

Recalling firm: Clinician's Choice Dental Products Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-03-18
Terminated: 2024-03-19
Firm location: Brookfield, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K053014 — POLY SILOXANE IMPRESSION MATERIALClinician'S Choice Dental Products, Inc.·cleared 2005-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.