CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER— 510(k) K080631

Name: FDA 510(k) clearance K080631
Creator: U.S. Food and Drug Administration
Published: 2008-05-23

Substantially Equivalent

Oral Health Technologies, LLC

FDA 510(k) clearance K080631 for CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER, Substantially Equivalent on 2008-05-23. Applicant: Oral Health Technologies, LLC. Device class: 1.

Clearance details

Applicant: Oral Health Technologies, LLC
Product code: Code EFT
Device class: Class 1
Regulation: 21 CFR 872.3520
Advisory panel: Dental
Date received: 2008-03-05
Decision date: 2008-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danville, CA, US

Download summary PDF View on FDA.gov ↗

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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.