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U.S. Department of Health and Human Services

Import Refusal Report
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Refusal Details as Recorded in OASIS by FDA

for Refusal UPS-8922021-2/8/1

Manufacturer FEI3008189393
Manufacturer NameSwiss Dental Instrument  
Manufacturer Address line 1Chemin De La Combe 5  
Manufacturer Address line 2  
Manufacturer's CityGlandgland  
Manufacturer Province/State  
Manufacturer Country/AreaSwitzerland  
Product Code76EJB  
Importer's Product DescriptionTIPS FOR DENTAL HAND INSTRUMENT  
Refusal Date25-Aug-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-8922021-2/8/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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