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U.S. Department of Health and Human Services

Class 2 Device Recall POLY Siloxane Impression Material

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  Class 2 Device Recall POLY Siloxane Impression Material see related information
Date Initiated by Firm March 18, 2022
Create Date May 17, 2022
Recall Status1 Terminated 3 on March 19, 2024
Recall Number Z-1100-2022
Recall Event ID 90031
510(K)Number K053014  
Product Classification Material, impression - Product Code ELW
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
Code Information LOT No.: 611612 (UDI): 07540172000178
Recalling Firm/
Manufacturer		 Clinician's Choice Dental Products Inc.
559 Federal Rd Unit B
Brookfield CT 06804-2017
Manufacturer 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
FDA Determined
Cause 2		 Process control
Action Clinicians Choice Dental Products Inc issued Urgent Product Recall Letter on 3/22/22 to the US Distributor. Please contact all Customers who purchased the aforementioned LOT after November 12, 2021 and inform them IMMEDIATELY to stop using the product and return it to Henry Schein. Additionally, please examine your inventory to determine if you have any of the aforementioned product(s) in stock. Please discontinue sale IMMEDIATELY and return the entire stock of the denoted lot number to Clinician's Choice. Lastly, please complete the provided Form F-011A - Product Recall Record and return to bwheal@clinicianschoice.com. Should you require any further information, please contact the undersigned at 1-800-265-3444 x 292
Quantity in Commerce 46 units
Distribution Distributed in SC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ELW and Original Applicant = CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
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