DENTURE PRODUCT X— 510(k) K914257

Substantially Equivalent

Essential Dental Systems, Inc.

FDA 510(k) clearance K914257 for DENTURE PRODUCT X, Substantially Equivalent on 1993-01-13. Applicant: Essential Dental Systems, Inc..

Clearance details

Applicant: Essential Dental Systems, Inc.
Product code: Code EFT
Advisory panel: Dental
Date received: 1991-09-23
Decision date: 1993-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Hackensack, NJ, US

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Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.