510(k) Report

510(k) · Cleared

Cleared

Stabident Local Anesthesia System

K910446510(k) TraditionalCleared Jun 3, 1991140-day reviewClass I21 CFR 872.4730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fairfax Dental, Inc. · DZM Needle, Dental

Cleared on Jun 3, 1991 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 3, 1991
Review
140 days
Class
Class I
Product code
DZM
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2010: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK910446 Stabident Local Anesthesia SystemFairfax Dental, Inc. · 1991
  2. Descendant · cites it directly · 2 of its ownK964802 Cyberjet Local Anesthesia SystemIntra Vantage, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK083811 W&H Handpiece Anesto, Model: RA-5W&H Dentalwerk Buermoos GmbH · 2010
  4. Descendant · 3 generations on · 0 of its ownK243427 QuickSleeper 5Dentalhitec · 2025

Most influential descendants

Showing 3 of 3 · See all
  • K964802Cyberjet Local Anesthesia SystemIntra Vantage, Inc. · 1997 · cites it directly2descendants
  • K083811W&H Handpiece Anesto, Model: RA-5W&H Dentalwerk Buermoos GmbH · 2010 · 2 generations on1descendant
  • K243427QuickSleeper 5Dentalhitec · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910446Stabident Local Anesthesia SystemFairfax Dental, Inc.1991—
+1K964802Cyberjet Local Anesthesia SystemIntra Vantage, Inc.1997—
+2K083811W&H Handpiece Anesto, Model: RA-5W&H Dentalwerk Buermoos GmbH2010—
+3K243427QuickSleeper 5Dentalhitec2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
201010
202510
FIG. 1 — Lineage of K910446, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DZM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K964802Cyberjet Local Anesthesia SystemIntra Vantage, Inc.19972

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.

What does this lineage say?

  • Of its descendants, K964802 (Intra Vantage, Inc., 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DZM devices

DZM Needle, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZM

FDA has decided no DZM device since 2007.

Median 510(k) review, days · DZM

Too few DZM 510(k)s in any year since 2007 to give a median.

Recalls per year · DZM

No recall names DZM since 2007.

Adverse event reports per year · DZM

11in 2025

2007: 142008: 232009: 1032010: 192011: 112012: 172013: 182014: 102015: 102016: 372017: 252018: 382019: 312020: 162021: 412022: 352023: 342024: 272025: 11
2007high 103 (2009) · low 10 (2014)2025

MAUDE reports naming product code DZM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—014
20080—023
20090—0103
20100—019
20110—011
20120—017
20130—018
20140—010
20150—010
20160—037
20170—025
20180—038
20190—031
20200—016
20210—041
20220—035
20230—034
20240—027
20250—011
20260—0—

Recent decisions in DZM

The DZM category page

  • K990511X-Tip Intraosseous PerforatorSchiff & Co. · 1999
  • K920758Jenker Needle Stick ProtectorDentsply Intl. · 1992
  • K914562Aseptic Dental Tech. Total Treatment SystemAseptic Dental Technologies, Inc. · 1992
  • K913573Safety Plus Dental Injection NeedleSpecialites Septodont · 1991
  • K910475Dental Needle Protective SystemHealth Technology Systems, Inc. · 1991

https://510kreport.com/device/K910446 · printed Nov 3, 2026

Cite this page

510(k) Report. “K910446: Stabident Local Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910446

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026