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Argen Clear Aligner

by Argen Corporation

510(k) K183229

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183229 Date7 Jun 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NXC
Device class
Class II
Regulation
21 CFR Part 872.5470
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Argen Clear Aligner is a removable dental appliance classified as a sequential aligner, designed to gradually reposition teeth for orthodontic correction. It is intended for use in treating anterior and premolar malocclusion, providing a clear, esthetic alternative to traditional braces.

These aligners are supplied as single-use, non-sterile devices and are manufactured from thermoformed plastic material. They are intended for use in dental offices and laboratories, with sizes and configurations tailored to individual patient needs. The device holds an FDA 510(k) clearance under the classification of Class II (NXC), with registration numbers including 2082148 and others listed. Storage and handling follow standard dental practice guidelines.

Devices cleared under K183229

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K183229
UDI-DISize and differences
retainer Argen retainer Premium
ARGEN CORPORATION, THE
125300 / Argen retainer PremiumD818125300 —On the market
template Argen template Premium
ARGEN CORPORATION, THE
127467 / Argen template PremiumD818127467 —On the market

Similar devices

Other devices filed under FDA product code NXC (Aligner, Sequential).

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