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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KERR CORPORATION POINT 4 COMPOSITE; TOOTH SHADE RESIN MATERIAL
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KERR CORPORATION POINT 4 COMPOSITE; TOOTH SHADE RESIN MATERIAL Back to Search Results
Catalog Number 29892
Device Problem Material Discolored (1170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Patient information with regard to age and weight was not provided.The composite veneers were removed and the patient was re-treated using point 4.To date, the patient is doing fine.The products involved in the alleged incident was evaluated, yielding results within specifications.
 
Event Description
A doctor alleged that a patient had experienced the yellowing of composite veneers.This is the first of two reports.
 
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Brand Name
POINT 4 COMPOSITE
Type of Device
TOOTH SHADE RESIN MATERIAL
Manufacturer (Section D)
KERR CORPORATION
1717 west collins avenue
orange CA 92867
Manufacturer (Section G)
KERR CORPORATION
1717 west collins avenue
orange CA 92867
Manufacturer Contact
mark dzendzel
1717 west collins avenue
orange, CA 92867
7145167802
MDR Report Key5082908
MDR Text Key25991503
Report Number2024312-2015-00078
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Report Date 08/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Expiration Date01/31/2018
Device Catalogue Number29892
Device Lot Number5516627
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/16/2015
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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