Cleared Special

TERA HARZ CLEAR

K240597 · Graphy, Inc. · Dental

Mar 2024

Decision

Days

Class 2

Risk

About This 510(k) Submission

K240597 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 March 5, 2024, 1 days after receiving the submission on March 4, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K240597 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2024
Decision Date	March 05, 2024
Days to Decision	1 days
Submission Type	Special
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.