510(k) Report

510(k) · Cleared

Cleared

Dental Syringe Tip

K931137510(k) TraditionalCleared Nov 29, 1993269-day reviewClass I21 CFR 872.4565

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

A-Dec, Inc. · ECB Unit, Syringe, Air And/Or Water

Cleared on Nov 29, 1993 after a 269-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Nov 29, 1993
Review
269 days
Class
Class I
Product code
ECB
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K931137Source: FDA 510(k) database · 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 ECB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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?

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 ECB devices

ECB Unit, Syringe, Air And/Or Water: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ECB

FDA has decided no ECB device since 2007.

Median 510(k) review, days · ECB

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

Recalls per year · ECB

No recall names ECB since 2007.

Adverse event reports per year · ECB

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code ECB, 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—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from A-Dec, Inc.

69 FDA decisions under this applicant name. See the company

  • K213932A-dec 300, A-dec 500A-Dec, Inc. · 2022
  • K133776A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
  • K102234A-Dec 200 Dental SystemA-Dec, Inc. · 2010
  • K100647A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMA-Dec, Inc. · 2010
  • K082716A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment…A-Dec, Inc. · 2009

Recent decisions in ECB

The ECB category page

  • K942519Uni-Syringe, Uni-Tip and Access Syringe TipsBull Frog Mfg. Co. · 1994
  • K931772Suretip Syringe Tip CoverWestern M/D, Inc. · 1994
  • K923876Riskontrol Single UseRiskontrol · 1993
  • K923285Pro-Tip Disposable 3/1 Syringe NozzleSmith & Nephew, Inc. · 1992
  • K920499Sani-TipDw Industries, Inc. · 1992

https://510kreport.com/device/K931137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931137: Dental Syringe Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931137

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