# K981997: Posi-Stop/Posi-Trac System

- Pathway: 510(k) (Traditional)
- Applicant: The Dental Medical Device Co., LLC
- Decided: Jan 12, 1999 after 218 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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 O0.5mm steps for final sizing for implant type customization. The Posi-Stop/Posi-Trac System is designed for use with or without a surgical guide. 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. *Osteotomy preparation is begun with a 1.6mm starter drill. The depth of the preparation should pierce the outer cortical bone and be about Smm in depth. If a surgical drill guide is used, the guide tube should have an inside diameter of 1.6mm and the starter drill should be tested in the guide tube to be certain that binding does not occur. *The length adjusted 1.6mm drill is placed into the osteotomy preparation and to the correct depth. It must be remembered the 1.6mm drill is the only depth cutting instrument; the remaining drills cut only on the outer 0.5mm to prevent excessive depth penetration. It is recommended that the osteotomy be prepared 1-2mm deeper than the length of the implant to allow for the exact placement of the coronal aspect of the implant in relation to the crestal bone. *After the 1.6mm osteotomy is prepared, a 2mm Posi-Trac drill is utilized. The pilot end of this instrument is 1-6mm (the diameter of the previous drill) and will fit easily into the osteotomy. The Posi-Trac drill is 8mm in length and should be used orily to widen the osteotomy to the next drill size. It should not be taken to length. After use of the Posi-Trac, the next length adjusted Posi-Stop instrument will be utilized until the correct width is achieved. : *Should during the course of preparation, the Posi-Stop (PSD 2) not fit interdentally, it may be removed by moving the Posi-Stop (PSD 2) to the colored size indicator ring (PSD 10) along the track guide (PSD S). The stop is rotated away from the operator until the locking screw assembly (PSD 2b) is on the drill flute, then removed by pulling it along the drill flute and over the cutting end. The Posi-Stop is simply replaced by reversing the procedure. The osteotomy can still be prepared safely since the 2.0 - 4. Smm sizes are safety ended.

Source page: https://510kreport.com/device/K981997
Methodology: https://510kreport.com/methodology