510(k) Report

FDA applicant

Essential Dental Systesm, Inc.

South Hackensack, NJ1 decision2015–20150 recalls

FDA records 1 decision for Essential Dental Systesm, Inc. (South Hackensack, NJ) in 2015: 1 510(k) clearance. All are in product code KJJ (Cleanser, Root Canal). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Essential Dental Systesm, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Essential Dental Systesm, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KJJCleanser, Root Canal1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K150020Irritrol, EDS Combo-RinseEssential Dental Systesm, Inc. · 2015

The one decision as Essential Dental Systesm, Inc. →

Other applicant names beginning “Essential”

FDA records each applicant name separately; these may or may not be the same firm.

Essential Dental Systems, Inc. 18Essential Medical Supply, Inc. 1