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510(k) Data Aggregation
K Number
K980106Device Name
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES
Manufacturer
Date Cleared
1998-08-03
(203 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
PROMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.
Device Description
Dental Operating Unit
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