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510(k) Data Aggregation
K Number
K193409Device Name
Vista Rinse, Vista Rinse Plus
Manufacturer
Inter-Med/Vista Dental Products
Date Cleared
2020-09-09
(275 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Inter-Med/Vista Dental Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.
Device Description
Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation. Both medical devices are packaged in bottles. Clinical use of the medical devices requires the irrigant to be expelled from syringes through irrigation tips, which are class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt.
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