Search Results
Found 1 results
510(k) Data Aggregation
K Number
K972644Device Name
BREATH-SO-FRESH TONGUE CLEANER
Manufacturer
INTL. DENTAL DESIGN SPECIALISTS, INC.
Date Cleared
1997-09-11
(58 days)
Product Code
LCN, ICN
Regulation Number
872.6855Why did this record match?
Applicant Name (Manufacturer) :
INTL. DENTAL DESIGN SPECIALISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
Device Description
The Breath-So-Fresh tongue cleaner is molded to a modified "spoon-shape". One end of the tongue cleaner is a handle. The other end is shaped as the bowl of the spoon. The tongue cleaner is held as a spoon, except upside down. The end tip of the spoon end is mildly rippled but has no sharp edges. The total length of the Breath-So-Fresh tongue cleaner is seven inches long and the cleaner is one and one-fourth inches wide at the widest portion.
The Breath-So-Fresh tongue cleaner is composed of a hard white plastic, either a polycarbonate plastic or a plastic similar to polycarbonate. This plastic is flexible as well as durable and is well suited to dental applications. The tongue cleaner is designed so that there are no sharp edges to the plastic.
Ask a Question
Page 1 of 1