Cleared Traditional

ULTRASONIC DENTURE CLEANER (K881391) - FDA 510(k) Clearance

Class I Dental device.

K881391 · Tatung Company of America, Inc. · Dental device
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Aug 1988
Decision
144d
Days
Class 1
Risk

K881391 is an FDA 510(k) clearance for the ULTRASONIC DENTURE CLEANER. Classified as Cleaner, Denture, Mechanical (product code JER), Class I - General Controls.

Submitted by Tatung Company of America, Inc. (Long Beach, US). The FDA issued a Cleared decision on August 26, 1988 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3530 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Tatung Company of America, Inc. devices

Submission Details

510(k) Number K881391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date August 26, 1988
Days to Decision 144 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 127d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JER Cleaner, Denture, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.