Z-1100-2022Class II

Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to...

Name: Z-1100-2022 Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to...
Creator: Clinician's Choice Dental Products Inc.
Published: 2022-03-18
License: https://open.fda.gov/license/

Den-Mat Holdings, LLC / initiated 2022-03-18 / Terminated / root cause: manufacturing process

FDA source

Clinician's Choice Dental Products Inc. began a recall of Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth... on 2022-03-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1100-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-18
Posted: 2022-05-17
Terminated: 2024-03-19
Recalling firm: Den-Mat Holdings, LLC
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
Product code: ELW Material, Impression
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
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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.
Product codes and lots: LOT No.: 611612 (UDI): 07540172000178

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1100-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1100-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-17

Product code ELW

K053014Class IIPoly Siloxane Impression MaterialClinician'S Choice Dental Products, Inc. / cleared 2005-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)