Cleared Special

TERA HARZ CLEAR (K240597) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240597 · Graphy, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
1d
Days
Class 2
Risk

K240597 is an FDA 510(k) clearance for the TERA HARZ CLEAR. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Graphy, Inc. (Seoul, KR). The FDA issued a Cleared decision on March 5, 2024 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Graphy, Inc. devices

Submission Details

510(k) Number K240597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Third Party Review Group, LLC
Dave Yungvirt

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.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K240597.
DigiLine Direct Print Aligner System
K233935 · Park Dental Research Corporation · Apr 2024
Clear Moves Aligners
K240038 · Space Maintainers Laboratories (Sml) · Apr 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K232653 · Blue Sky Bio, LLC · Apr 2024
Serafin®
K232074 · Tns Co., Ltd. · Feb 2024
MESHEET
K233544 · Dentis Co., Ltd. · Feb 2024
Invisalign Palatal Expander System
K232887 · Align Technology, Inc. · Dec 2023