TERA HARZ Hard Denture (THD-C-500); 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)

FDA 510(k) K253681 · Graphy, Inc.

Substantially Equivalent

510(k) numberK253681

Submission

Device name
TERA HARZ Hard Denture (THD-C-500); 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)
Applicant
Graphy, Inc.
Seoul, KR
Received
November 21, 2025
Decision date
November 21, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
EBI – Resin, Denture, Relining, Repairing, Rebasing
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3760
Specialty
Dental

Other 510(k)s with product code EBI

510(k)DeviceApplicantDecision
K261802Glidewell™ Denture Base ResinEBI · Traditional Prismatik Dentalcraft, Inc.08/27/2026SE
K261626UltraPrint Flexible Denture UVEBI · Traditional Guangzhou Heygears IMC., Inc.08/13/2026SE
K262681NanoCeram ResinEBI · Traditional 3BFAB Teknoloji A.S.07/31/2026SE
K262300Denture Base Resin V2EBI · Abbreviated Formlabs Ohio, Inc.07/08/2026SE
K261474DENTCA Tru FlexibleEBI · Traditional Dentca, Inc.07/01/2026SE
K260569DB 4000 High Impact Denture BaseEBI · Abbreviated Carbon, Inc.06/02/2026SE
K260376Denture BaseEBI · Traditional Shandong Huge Dental Material Corporation05/06/2026SE
K253365LuxCreo Flexible Partial Denture ResinEBI · Traditional LuxCreo, Inc.11/25/2025SE
K253324UltraPrint-Dental Denture UVEBI · Traditional Guangzhou Heygears IMC., Inc.11/20/2025SE
K252430Freeprint® denture flexEBI · Traditional Detax GmbH10/30/2025SE

More from Detax GmbH

510(k)DeviceDecision
K240597Tera Harz ClearNXC · Special 03/05/2024SE
K233502Tera Harz IIEBF · Traditional 11/01/2023SE
K223355Tera Harz ClearNXC · Traditional 11/03/2022SE
K222414Tera Harz DentureEBI · Traditional 08/11/2022SE
K202846Tera HarzEBF · Traditional 07/15/2021SE

Questions and answers

When was TERA HARZ Hard Denture (THD-C-500); 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) cleared by the FDA?

TERA HARZ Hard Denture (THD-C-500); 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) (K253681) received a 510(k) decision of Substantially Equivalent on November 21, 2025, 0 days after the submission was received.

What is the product code of K253681?

The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.