Search Results
Found 1 results
510(k) Data Aggregation
K Number
K062502Device Name
OSSPRAY CLEANING COMPOUND
Manufacturer
OSPRAY, LTD.
Date Cleared
2006-12-15
(112 days)
Product Code
EJR
Regulation Number
872.6030Why did this record match?
Applicant Name (Manufacturer) :
OSPRAY, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.
Device Description
The OSspray Cleaning Compound is a biocompatible calcium sodium phosphosilicate compound in powder form intended for cleaning and polishing procedures as part of a dental prophylaxis treatment to remove debris from tooth surfaces. The OSspray Cleaning Compound is also intended to physically occlude dentin tubules to provide relief from tooth sensitivity during the prophylaxis treatment. The process of cleaning the tooth surface with the OSspray Cleaning Compound physically occludes dentin tubules for the management of sensitive teeth. The OSspray Cleaning Compound is a dry inorganic particulate (calcium sodium phosphosilicate) composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, the OSspray Cleaning Compound undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles of the compound react to form hydroxycarbonate apatite (HCA), which is chemically similar to natural tooth mineral.
Ask a Question
Page 1 of 1