510(k) Report

510(k) · Cleared

Cleared

Flexi-Post

K843018510(k) TraditionalCleared Sep 27, 198457-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

Essential Dental Systems, Inc. · ECR Setter, Band, Orthodontic

Cleared on Sep 27, 1984 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 27, 1984
Review
57 days
Class
Class I
Product code
ECR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K843018Source: 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.

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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?

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 ECR devices

ECR Setter, Band, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ECR

FDA has decided no ECR device since 2007.

Median 510(k) review, days · ECR

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

Recalls per year · ECR

No recall names ECR since 2007.

Adverse event reports per year · ECR

1in 2022

2017: 12022: 1
2007high 1 (2017) · low 0 (2007)2025

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

More from Essential Dental Systems, Inc.

17 FDA decisions under this applicant name. See the company

  • K223340EDS Calculus Softener TURBO CREssential Dental Systems, Inc. · 2023
  • K152691EDS Universal CementEssential Dental Systems, Inc. · 2016
  • K140846Eds Combo-RinseEssential Dental Systems, Inc. · 2014
  • K132609Eds Ultrasonic TipsEssential Dental Systems, Inc. · 2014
  • K111541Endo-Express (R) HandpieceEssential Dental Systems, Inc. · 2012

Recent decisions in ECR

The ECR category page

  • K951776Band SeaterOrmco Corp. · 1995
  • K935156Dentaurum Band Seater and Band Seating InstrumentsDentauraum, Inc. · 1994

https://510kreport.com/device/K843018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K843018: Flexi-Post.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843018

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