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Adverse Event Report

L.D. CAULK ENFORCE DENTAL CEMENT   back to search results
Event Date 01/01/1999
Event Type  Injury   Patient Outcome  Other;
Event Description

The dentist alleges that in 03/2001 he began to see failures in pts who had crowns cemented with enforce in late 1999 and early 2000. Several pts had decay serious enough to require extractions.

 
Manufacturer Narrative

Enforce is no longer on the market. It has been discontinued.

 
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Brand NameENFORCE
Type of DeviceDENTAL CEMENT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
L.D. CAULK
38 west clarke ave.
p.o. box 359
milford DE 19963 0359
Manufacturer (Section D)
L.D. CAULK
38 west clarke ave.
p.o. box 359
milford DE 19963 0359
Manufacturer Contact
william frey, jr
570 w college ave
p.o. box 872
york , PA 17405-0872
(717) 845 -7511
Device Event Key337736
MDR Report Key348416
Event Key328147
Report Number2515379-2001-00010
Device Sequence Number1
Product CodeEMA
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation DENTIST
Type of Report Initial
Report Date 08/16/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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