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510(k) Data Aggregation
K Number
K983683Device Name
UNIK TONGUE CLEANER
Manufacturer
UNIK PRODUCTS, INC.
Date Cleared
1999-01-14
(86 days)
Product Code
LCN
Regulation Number
872.6855Why did this record match?
Applicant Name (Manufacturer) :
UNIK PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.
Device Description
This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue and gently dragging it toward the front. The device is designed so that there are no sharp edges.
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