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510(k) Data Aggregation
K Number
K981997Device Name
POSI-STOP/POSI-TRAC SYSTEM
Manufacturer
Date Cleared
1999-01-12
(218 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
THE DENTAL MEDICAL DEVICE CO., L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion. The Posi-Stop/Posi-Trac System is designed for use with or without a surgical guide. The system allows the dental practitioner to increase size gradations in 0.5mm steps for final sizing for implant type customization. The system is truly generic in that its 0.5mm size gradations allows the doctor to switch to a final sizing drill for implant type customization.
Device Description
The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion. The system is designed for use with or without a surgical guide and allows for size gradations in 0.5mm steps for final sizing for implant type customization. The system includes a 1.6mm starter drill, Posi-Trac drills, and Posi-Stop instruments. The 1.6mm drill is the only depth cutting instrument, while the remaining drills cut only on the outer 0.5mm to prevent excessive depth penetration. The Posi-Trac drill has a pilot end of 1.6mm and is used to widen the osteotomy. The Posi-Stop instrument is utilized until the correct width is achieved. The Posi-Stop can be adjusted along a track guide. The 2.0 - 4.5mm sizes are safety ended.
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