Cleared Traditional

TERA HARZ II (K233502) - FDA 510(k) Clearance

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

K233502 · Graphy, Inc. · Dental device
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Nov 2023
Decision
1d
Days
Class 2
Risk

K233502 is an FDA 510(k) clearance for the TERA HARZ II. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Graphy, Inc. (Seoul, KR). The FDA issued a Cleared decision on November 1, 2023 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K233502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2023
Decision Date November 01, 2023
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
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 EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 Peers - EBF Material, Tooth Shade, Resin

All 291
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