FDA applicant
Essential Dental Systems, Inc.
FDA records 18 decisions for Essential Dental Systems, Inc. (South Hackensack, NJ) from 1984 to 2023: 18 510(k) clearances. Most are in product codes EMA (Cement, Dental) and KJJ (Cleanser, Root Canal). Since 2016 its 510(k)s took a median of 184 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Essential Dental Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Essential Dental Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Essential Dental Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Essential”
FDA records each applicant name separately; these may or may not be the same firm.