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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK SUREFLI SDR FLOW; TOOTH SHADE RESIN MATERIAL
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DENTSPLY CAULK SUREFLI SDR FLOW; TOOTH SHADE RESIN MATERIAL Back to Search Results
Catalog Number 61C030
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Increased Sensitivity (2065)
Event Type  Injury  
Event Description
In this case, it was reported that several patients experienced post-operative sensitivity after undergoing a procedure that included the use of sdr flow in addition to products from another manufacturer.The dentist stated that he removed the sdr flow and replaced it with other material.
 
Manufacturer Narrative
Follow up with the clinician revealed that adhesive placement technique may be a contributing cause to the sensitivity.Therefore, because intervention was required, this event is reportable per 21 cfr part 803.The device was evaluated and found to be within specification.
 
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Brand Name
SUREFLI SDR FLOW
Type of Device
TOOTH SHADE RESIN MATERIAL
Manufacturer (Section D)
DENTSPLY CAULK
milford DE
Manufacturer Contact
helen lewis
221 w. philadelphia st.
ste. 60
york, PA 17401
7178457511
MDR Report Key4759712
MDR Text Key5790196
Report Number2515379-2015-00034
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083841
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 04/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number61C030
Device Lot Number140905
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/22/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
HELIMOLAR; SCOTCHBOND
Patient Outcome(s) Required Intervention;
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