Cleared Traditional

K881391 - ULTRASONIC DENTURE CLEANER

K881391 is an FDA 510(k) clearance for ULTRASONIC DENTURE CLEANER, manufactured by Tatung Company of America, Inc.. The device is a Class 1 Dental device with product code JER cleared through the Traditional 510(k) pathway after a 144-day FDA review.

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

FDA 510(k) Submission Details - K881391

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
16d slower than avg
Panel avg: 128d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

JER Device Classification - Class 1, General Controls

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.