510(k) · Cleared
ClearedPosi-Stop/Posi-Trac System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Dental Medical Device Co., LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jan 12, 1999 after a 218-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 12, 1999
- Review
- 218 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
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…
Read the full statement (410 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981997: Posi-Stop/Posi-Trac System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981997
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026