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510(k) Data Aggregation
K Number
K040117Device Name
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
Manufacturer
Date Cleared
2004-04-21
(92 days)
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
ARROW INDUSTRIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended for delivery of general restorative dental care for those who cannot visit the dental office.
Device Description
The UNIPORT has been designed to provide ease in set-up and transportation as well as good dental care. Reliable air supply being an utmost necessity, it has 9.8 L of air storage supplied by a 3/4 hp compressor to maintain pressure during daily practice. For ease in set-up, take-down, and transport, the UNIPORT is truly self-contained - all components are mounted in a lightweight unitized cabinet with wheels. The cabinet, a shell containing the operational components, is made of food grade polyethylene for durability; its smooth exterior is easy to wipe down and disinfect between operations. While the outside of the UNIPORT appears different to others, the actual operating components are similiar to those used in dental clinics around the nation.
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