TATUNG'S DENTURE CLEANING SOLUTION— 510(k) K874805

Name: FDA 510(k) clearance K874805
Creator: U.S. Food and Drug Administration
Published: 1988-02-16

Substantially Equivalent

Tatung Company of America, Inc.

FDA 510(k) clearance K874805 for TATUNG'S DENTURE CLEANING SOLUTION, Substantially Equivalent on 1988-02-16. Applicant: Tatung Company of America, Inc.. Device class: 1.

Clearance details

Applicant: Tatung Company of America, Inc.
Product code: Code EFT
Device class: Class 1
Regulation: 21 CFR 872.3520
Advisory panel: Dental
Date received: 1987-11-23
Decision date: 1988-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Beach, CA, US

Download summary PDF View on FDA.gov ↗

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K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND2000-06-16
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K881391 — ULTRASONIC DENTURE CLEANER1988-08-26

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.