510(k) Report

510(k) · Cleared

Cleared

Safety Plus Dental Injection Needle

K913573510(k) TraditionalCleared Nov 7, 199187-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

Specialites Septodont · DZM Needle, Dental

Cleared on Nov 7, 1991 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 7, 1991
Review
87 days
Class
Class I
Product code
DZM
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK913573 Safety Plus Dental Injection NeedleSpecialites Septodont · 1991
  2. Descendant · cites it directly · 1 of its ownK022959 Safestep Safety Dental Cartridge Injector, Model 33-00000-1MDC Research, Ltd. · 2003
  3. Descendant · 2 generations on · 0 of its ownK043322 Miramatic Safe Syringe SystemHager Worldwide, Inc. · 2005

Most influential descendants

Showing 2 of 2 · See all
  • K022959Safestep Safety Dental Cartridge Injector, Model 33-00000-1MDC Research, Ltd. · 2003 · cites it directly1descendant
  • K043322Miramatic Safe Syringe SystemHager Worldwide, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913573Safety Plus Dental Injection NeedleSpecialites Septodont1991—
+1K022959Safestep Safety Dental Cartridge Injector, Model 33-00000-1MDC Research, Ltd.2003—
+2K043322Miramatic Safe Syringe SystemHager Worldwide, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
FIG. 1 — Lineage of K913573, 1991–2005Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K022959Safestep Safety Dental Cartridge Injector, Model 33-00000-1MDC Research, Ltd.20031

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, K022959 (MDC Research, Ltd., 2003) has gone furthest, with 1 descendant 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—

More from Specialites Septodont

21 FDA decisions under this applicant name. See the company

  • K012427Pharmaethyl Local Pulp and Vitality Testing AgentSpecialites Septodont · 2001
  • K010415IsodanSpecialites Septodont · 2001
  • K982773Quickset Liquid and PowderSpecialites Septodont · 1998
  • K982671SecuralloySpecialites Septodont · 1998
  • K980633Endosolv ESpecialites Septodont · 1998

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
  • K910475Dental Needle Protective SystemHealth Technology Systems, Inc. · 1991
  • K910446Stabident Local Anesthesia SystemFairfax Dental, Inc. · 1991

https://510kreport.com/device/K913573 · printed Nov 5, 2026

Cite this page

510(k) Report. “K913573: Safety Plus Dental Injection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K913573

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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