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510(k) Data Aggregation
K Number
K042828Device Name
OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
Manufacturer
YOUNG O/S LLC
Date Cleared
2004-12-01
(50 days)
Product Code
EKR
Regulation Number
872.4565Why did this record match?
Applicant Name (Manufacturer) :
YOUNG O/S LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Obtura is intended for used by professionally qualified dentists, endodontists and dental clinicians to heat Gutta Percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
Device Description
The device is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during rot canal therapy. The Obtura is an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide. This model incorporates interchangeable handpieces, membrane switches and temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate Heated Gutta Percha System, #K832654.
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