Cleared Traditional

Klinly Ultrasonic Tongue Cleaner (K181986) - FDA 510(k) Clearance

Class I Dental device.

K181986 · Kea Products, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
408d
Days
Class 1
Risk

K181986 is an FDA 510(k) clearance for the Klinly Ultrasonic Tongue Cleaner. Classified as Powered Tongue Scraper (product code QIA), Class I - General Controls.

Submitted by Kea Products, Ltd. (Kwun Tong, HK). The FDA issued a Cleared decision on September 6, 2019 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Kea Products, Ltd. devices

Submission Details

510(k) Number K181986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2018
Decision Date September 06, 2019
Days to Decision 408 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
281d slower than avg
Panel avg: 127d · This submission: 408d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QIA Powered Tongue Scraper
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
Definition The Device Is Intended To Remove Debris From The Top Surface Of The Tongue As A Supplement To Normal Daily Oral Hygiene Care.
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.

Regulatory Consultant

Robert T. Bock Consultancy, LLC
Robert T. Bock

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.