Cleared Traditional

Tera Harz Clear

K223355 · Graphy, Inc. · Dental

Nov 2022

Decision

Days

Class 2

Risk

About This 510(k) Submission

K223355 is an FDA 510(k) clearance for the Tera Harz Clear, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Graphy, Inc. (Seoul, KR). The FDA issued a Cleared decision on November 3, 2022, 1 days after receiving the submission on November 2, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K223355 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2022
Decision Date	November 03, 2022
Days to Decision	1 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NXC — Aligner, Sequential
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.5470
Definition	The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.