Cleared Traditional

K253681 - TERA HARZ Hard Denture (THD-C-500) (FDA 510(k) Clearance)

Also includes:
TERA HARZ Hard Denture (THD-C-1000) TERA HARZ Hard Denture (THD-LP-500) TERA HARZ Hard Denture (THD-LP-1000) TERA HARZ Hard Denture (THD-P-500) TERA HARZ Hard Denture (THD-P-1000) TERA HARZ Hard Denture (THD-CP-500) TERA HARZ Hard Denture (THD-CP-1000)

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

K253681 · Graphy, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
-
Days
Class 2
Risk

K253681 is an FDA 510(k) clearance for the TERA HARZ Hard Denture (THD-C-500). Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Graphy, Inc. (Seoul, KR). The FDA issued a Cleared decision on November 21, 2025.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Graphy, Inc. devices

Submission Details

510(k) Number K253681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2025
Decision Date November 21, 2025
Days to Decision -
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
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 327
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K253681.
LuxCreo Flexible Partial Denture Resin
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UltraPrint-Dental Denture UV
K253324 · Guangzhou Heygears IMC., Inc. · Nov 2025
Freeprint® denture flex
K252430 · Detax GmbH · Oct 2025
DENTURE SOFT EX (Pink set)
K252035 · Kamemizu Chemical Industry Co., Ltd. · Sep 2025
Flexible Partial Resin
K250302 · Prismatik Dentalcraft, Inc. · Jun 2025
Partial Flex
K242897 · Clemde SA DE CV · Jun 2025