Cleared Traditional

Tera Harz Clear (K223355) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223355 · Graphy, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2022
Decision
1d
Days
Class 2
Risk

K223355 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 November 3, 2022 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Graphy, Inc. devices

Submission Details

510(k) Number K223355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
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
Predicate-based equivalence. No clinical trials required. 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 K223355.
Invisalign System, Pre-Formed Attachment System
K222894 · Align Technology, Inc. · Dec 2022
Al Smile Aligner
K222308 · Nanjing Jiahe Dental Technology Co., Ltd. · Dec 2022
DentCare Aligners
K222918 · Dentcare Dental Lab Pvt , Ltd. · Nov 2022
CREOKORREKT Aligners
K211427 · Creodent Prosthetics, Ltd. · Oct 2022
Nuvola
K222418 · Gruppo Europeo Ortodonzia Srl · Oct 2022
ClearCorrect System
K220140 · Clearcorrect, LLC · Oct 2022