DENTURE PRODUCT X— 510(k) K914257

Name: FDA 510(k) clearance K914257
Creator: U.S. Food and Drug Administration
Published: 1993-01-13

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.. Device class: 1.

Clearance details

Applicant: Essential Dental Systems, Inc.
Product code: Code EFT
Device class: Class 1
Regulation: 21 CFR 872.3520
Advisory panel: Dental
Date received: 1991-09-23
Decision date: 1993-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFT

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K080631 — CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER2008-05-23
K051342 — MEDICAL INTERPOROUS2006-06-02
K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND2000-06-16
K942203 — OTC DENTURE CLEANSER1994-08-10
K930337 — PROFAST(R)-DENTURE CLEANSER1993-09-07

More clearances from Essential Dental Systems, Inc.

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K223340 — EDS Calculus Softener TURBO CR2023-12-11
K152691 — EDS Universal Cement2016-02-25
K140846 — EDS COMBO-RINSE2014-07-25
K132609 — EDS ULTRASONIC TIPS2014-01-22
K111541 — ENDO-EXPRESS (R) HANDPIECE2012-03-16

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.