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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES KAVO MULTIFLEX COUPLING 457 HANDPIECE, AIR-POWERED DENTAL

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KAVO DENTAL TECHNOLOGIES KAVO MULTIFLEX COUPLING 457 HANDPIECE, AIR-POWERED DENTAL Back to Search Results
Model Number 0.553.1210
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Considered by the fda to be a dental device/equipment and should be reprocessed if detachable. The kavo multiflex coupling 457-0. 553. 1210 is a detachable device, however the mfr has rendered this item non-sterilisable. Mfrs who state their couplers are not a medical device should be reported to the fda via their medwatch program. Equipment that can be removed from the dental unit lines should be cleaned and sterilized between each pt according to the mfr's validated ifu for the item. The cdc is not a regulatory agency and does not publish regulations or other legally enforceable standards. Cdc's role is to provide guidelines and recommendations related to infection prevention in dental health care settings and to provide overall guidance on infection prevention practices. These guidelines represent the minimum standard of practice recommended for safe care in all dental settings and are designed to prevent transmission of infectious agents among pts and dental health care personnel in dental settings.
 
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Brand NameKAVO MULTIFLEX COUPLING 457
Type of DeviceHANDPIECE, AIR-POWERED DENTAL
Manufacturer (Section D)
KAVO DENTAL TECHNOLOGIES
charlotte NC 28273
MDR Report Key8470980
MDR Text Key141025020
Report NumberMW5085447
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0.553.1210
Device Catalogue Number457
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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