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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IVOCLAR VIVADENT AG VARIOLINK VENEER MATERIAL, TOOTH SHADE, RESIN

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IVOCLAR VIVADENT AG VARIOLINK VENEER MATERIAL, TOOTH SHADE, RESIN Back to Search Results
Catalog Number 591425AN
Device Problems Fluid Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Customer complained that the material did not polymerize properly when used with the bluephase style curing light. Due to a darkening under the crowns (microleakage), the health care professional had to cut off all of the restorations.
 
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Brand NameVARIOLINK VENEER
Type of DeviceMATERIAL, TOOTH SHADE, RESIN
Manufacturer (Section D)
IVOCLAR VIVADENT AG
bendererstrasse 2
schaan, ls 9494
LS 9494
Manufacturer (Section G)
IVOCLAR VIVADENT AG
bendererstrasse 2
schaan, li 9494
LS 9494
Manufacturer Contact
donna hartnett
175 pineview drive
amherst, NY 14228
7166912260
MDR Report Key6456204
MDR Text Key71907280
Report Number9612352-2017-00002
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K901917
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 03/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Catalogue Number591425AN
Device Lot NumberU33189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1
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