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510(k) Data Aggregation
K Number
K980968Device Name
LONE STAR IMPRESSION SYSTEMS
Manufacturer
LONE STAR TECHNOLOGIES
Date Cleared
1998-06-09
(85 days)
Product Code
ELW, EZW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
LONE STAR TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in taking the final Impression of prepared teeth in adult or deciduous teeth when the dentist has determined that a crown or a bridge is needed. The dentist examines the patient and determines the need for a crown or bridge. They then prepare the teeth or tooth in their usual manner. The two component impression material is then mixed manually or automatically and placed into an impression tray of the dentists' choosing. The material is then placed in the mouth and allowed to set, approx. 4 minutes, resulting in an impression of the prepared teeth. The resulting impression is then disinfected and a model is poured from this impression for use by the dentist or dental lab in preparation of the crown or bridge that is to be constructed.
Device Description
Impression Material
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K Number
K981234Device Name
FLARE,FILE, FILL
Manufacturer
LONE STAR TECHNOLOGIES
Date Cleared
1998-06-05
(62 days)
Product Code
EJB
Regulation Number
872.4565Why did this record match?
Applicant Name (Manufacturer) :
LONE STAR TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in the preparation of root canals prior to the final filling of the root canals in adult or deciduous teeth. The Dentist or Endodontist examines the patient to determine if the method of treatment is to be the removal of the root canal for the appropriate reasons. After opening the tooth with the access bur the first part of the root canal is exposed to the point where the canals tend to branch out about one third of the way. The Dentist then follows his standard procedure of locating the Apex and removal of the nerve and decayed matter from the canal using the Flare--File -- Fill procedures.
Device Description
Not Found
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