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510(k) Data Aggregation
K Number
K960889Device Name
SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS
Manufacturer
SAN DIEGO SWISS MACHINING, INC.
Date Cleared
1996-05-10
(67 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SAN DIEGO SWISS MACHINING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The San Diego Swiss Machining Sapphire Plus® Tips are utilized in reconstructive dental procedures (crown preparation), periodontic preparative procedures, tissue scaling, plaque/bone removal, endodontic retreatment and root preparation. The devices are used during dertal cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodentic applications to prepare the tooth and/or root of the tooth for repair.
Device Description
Four different types of tips will be manufactured by San Diego Swiss Machining as follows: Scaler Tips, Plugger Tips, Cutting Tips, Spreader Tips. The tips have been designed with an assortment of bends and/or angles to allow greater flexibility during debridment, cleansing, irrigation, disinfection, canal shaping and other various endodontic applications. The tips will be made of 13-8 stainless steel and coated with titanium nitride and/or zirconium nitride mater als.
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