Search Results
Found 1 results
510(k) Data Aggregation
K Number
K984415Device Name
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
Manufacturer
Date Cleared
1999-09-29
(293 days)
Product Code
Regulation Number
872.6080Why did this record match?
Applicant Name (Manufacturer) :
S.S. WHITE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The S.S. White Technologies 6500 Series Air Abrasion Devices are used for cavity preparation in Classes I, II, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. They are also used for restoration prophylaxis.
Device Description
The 6500-D, 6500-E, and 6500-F are pneumatic devices which combine pressurized air and abrasive powder (e.g. aluminum oxide or sodium bicarbonate) to produce a high velocity stream of particles to perform dental restorative procedures. The abrasive particulate is delivered via a small handpiece which is approximately the size of a dental drill handpiece. The systems are designed for ease of service and maintenance with a readily accessible refillable container for the particulate supply.
Ask a Question
Ask a specific question about this device
Page 1 of 1