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TP Orthodontics Clear Aligner System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193385

by Tp Orthodontics, Inc.

Identifiers

510(k) Number
K193385 FDA 510(k)
FDA Product Code
NXC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.5470 FDA 510(k)
Regulation Number
872.5470 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TP Orthodontics Clear Aligner System is a removable orthodontic appliance designed for the sequential correction of tooth malocclusions in patients with fully erupted permanent dentition. Classified as a sequential aligner, it applies incremental, gentle forces to reposition teeth over a series of custom-fitted plastic trays, addressing crowding, spacing, and alignment issues in the anterior and posterior dentition.

This system is intended for use in orthodontic offices and dental clinics under professional supervision. Supplied as a series of single-use aligners, each tray is tailored to specific stages of treatment progression. The device has received FDA 510(k) clearance under the classification of Class II (NXC), with registration number 872.5470 and K-number K193385. No third-party review was required for this submission.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - TP Orthodontics, Products - TP Orthodontics, TP Orthodontics Clear Aligner System (K193385) — FDA 510 (k ..., Products - TP Orthodontics, Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tp Orthodontics, Inc.

Sources (1)

  • FDA 510(k) K193385 24 fields · synced Oct 1, 2026