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TERA HARZ Denture

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K222414Ref noneModel THD-C-1000,THD-LP-1000,THD-P-1000,THD-CP-1000,TFDH-LP-1000,TFDH-P-1000,TFDH-DP-1000,TFDH-BP-1000,TFDH-C-1000,TFDH-W-1000

by Graphy Inc.

Identity

Trade Name
TERA HARZ DENTURE EUDAMEDFDA UDI
Generic Name
Dental appliance fabrication material, resin FDA UDI
Device Name
TERA HARZ DENTURE, Tera Harz Denture EUDAMED
The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment. FDA UDI
Model / Reference
THD-C-1000,THD-LP-1000,THD-P-1000,THD-CP-1000,TFDH-LP-1000,TFDH-P-1000,TFDH-DP-1000,TFDH-BP-1000,TFDH-C-1000,TFDH-W-1000 EUDAMED
none EUDAMED
TFDH-W-1000 FDA UDI
TFDH-LP-1000 FDA UDI
TFDH-C-1000 FDA UDI
TFDH-DP-1000 FDA UDI
TFDH-P-1000 FDA UDI
TFDH-BP-1000 FDA UDI
Description
The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment. FDA UDI

Identifiers

Catalog Number
NONE FDA UDI
Primary DI / UDI-DI
08800142100536 EUDAMEDFDA UDI
08800142100550 EUDAMEDFDA UDI
08800142100512 EUDAMEDFDA UDI
08800142100598 EUDAMEDFDA UDI
08800142100574 EUDAMEDFDA UDI
08800142100499 EUDAMEDFDA UDI
08800142100406 EUDAMED
08800142100475 EUDAMED
08800142100451 EUDAMED
Basic UDI-DI
88001421THDW4 EUDAMED
Direct Marketing DI
08800142100499 EUDAMED
08800142100536 EUDAMED
08800142100512 EUDAMED
08800142100574 EUDAMED
08800142100598 EUDAMED
08800142100406 EUDAMED
08800142100550 EUDAMED
510(k) Number
K222414 FDA 510(k)FDA UDI
FDA Product Code
EBI FDA 510(k)FDA UDI
EMDN Code
Q01020605 TEMPORARY DENTAL PROSTHESES EUDAMED
GMDN Term
Dental appliance fabrication material, resin FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3760 FDA 510(k)
Regulation Number
872.3760 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

The TERA HARZ Denture is a dental prosthesis designed to replace missing teeth and restore oral function. Classified under the product code EBI, it is intended for partial or complete tooth replacement, providing structural and aesthetic support to the oral cavity.

This denture is supplied as a reusable device and is regulated under the FDA’s 510(k) clearance process, with a decision dated 2022-08-11. Manufactured by Graphy Inc., it adheres to dental standards and is intended for professional fitting by dental practitioners. No specific sterility or MRI safety information is provided in the data.

Frequently asked questions

What types of dental issues is the TERA HARZ Denture designed to address, and how does it differ from other dentures?

The TERA HARZ Denture is specifically designed to replace missing teeth for either partial or complete tooth loss, helping restore both oral function and aesthetics. Unlike some dentures that may only address one of these needs, this prosthesis combines structural support with visual appeal, making it suitable for patients requiring comprehensive dental restoration. It is classified under product code EBI, indicating its role as a removable dental prosthesis.

Is the TERA HARZ Denture intended for single-use or reusable applications, and how does this affect its maintenance?

The TERA HARZ Denture is explicitly described as a reusable device, meaning it is meant to be professionally fitted and used repeatedly by patients. Since it is not single-use, proper maintenance—such as regular cleaning and periodic professional adjustments—is essential to ensure longevity, hygiene, and continued functionality. The reusable nature also aligns with its classification as a dental prosthesis requiring ongoing care by dental practitioners.

What regulatory pathway did the TERA HARZ Denture follow to gain market authorization, and what does this mean for clinicians?

The TERA HARZ Denture was cleared through the FDA’s 510(k) process, specifically under a *Traditional* clearance type, with a decision dated 2022-08-11. This means the device was determined to be *substantially equivalent* to a legally marketed predicate, ensuring it meets established dental safety and performance standards. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though professional fitting and follow-up care remain critical for patient outcomes.

Does the TERA HARZ Denture come with any specific sterility guarantees or MRI safety considerations?

The provided data does not include details about sterility guarantees for the TERA HARZ Denture, so clinicians should follow standard dental protocols for cleaning and sterilizing reusable prosthetics before patient use. Additionally, there is no mention of MRI safety in the documentation, meaning patients should confirm compatibility with their MRI facility if imaging is required, as dentures may contain metallic components that could interfere with scans.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Graphy Inc.
FDA Applicant
Graphy, Inc.

Sources (25)

  • FDA 510(k) K222414 24 fields · synced Sep 18, 2026
  • FDA UDI 5596648f-69ee-4cdc-8cf9-03d583544c89 36 fields · synced May 30, 2026
  • FDA UDI cd46cb49-a283-4715-a985-1a275dd0ab38 36 fields · synced May 30, 2026
  • FDA UDI c5d936a1-a4ac-452c-862c-f0a5ac03daac 36 fields · synced May 30, 2026
  • FDA UDI 52babdd2-170a-402e-9903-b5c7ff4607c6 36 fields · synced May 30, 2026
  • FDA UDI 217c28a5-0058-4c04-a6c9-5b82530877c0 36 fields · synced May 30, 2026
  • FDA UDI 74f884f0-2a86-4546-a06e-aafcaf9405cc 36 fields · synced May 30, 2026
  • EUDAMED 0b678c13-555c-4fe0-91d9-1de9b479e0d1-1 61 fields · synced Jul 9, 2026
  • EUDAMED 0b678c13-555c-4fe0-91d9-1de9b479e0d1-2 61 fields · synced Jul 9, 2026
  • EUDAMED 6814fc4c-8b9b-4355-9061-f843926298a8-1 61 fields · synced Jul 13, 2026
  • EUDAMED 6814fc4c-8b9b-4355-9061-f843926298a8-2 61 fields · synced Jul 13, 2026
  • EUDAMED a8d35e64-64b8-4e7c-8c7c-b35164717def-1 61 fields · synced Jul 14, 2026
  • EUDAMED a8d35e64-64b8-4e7c-8c7c-b35164717def-2 61 fields · synced Jul 14, 2026
  • EUDAMED d55303c2-fc25-4d8c-b33a-0c4369a9fe4b-1 61 fields · synced Jul 15, 2026
  • EUDAMED d55303c2-fc25-4d8c-b33a-0c4369a9fe4b-2 61 fields · synced Jul 15, 2026
  • EUDAMED f448dd9f-6ba7-44c4-82a6-17e2ebc5080c-1 61 fields · synced Jul 16, 2026
  • EUDAMED f448dd9f-6ba7-44c4-82a6-17e2ebc5080c-2 61 fields · synced Jul 16, 2026
  • EUDAMED 703a966d-0582-4949-aee6-40df78125599-1 61 fields · synced Jul 17, 2026
  • EUDAMED 703a966d-0582-4949-aee6-40df78125599-2 61 fields · synced Jul 17, 2026
  • EUDAMED a0dd3ea4-7d6d-46e8-b5b3-b1d96643e726-1 61 fields · synced Jul 20, 2026
  • EUDAMED a0dd3ea4-7d6d-46e8-b5b3-b1d96643e726-2 61 fields · synced Jul 20, 2026
  • EUDAMED eee64bb8-b316-42b8-9d7d-c5a7a28064af-1 61 fields · synced Jul 20, 2026
  • EUDAMED eee64bb8-b316-42b8-9d7d-c5a7a28064af-2 61 fields · synced Jul 20, 2026
  • EUDAMED 8a23bb24-1fc4-4112-94a2-ff58df36242a-1 61 fields · synced Jul 23, 2026
  • EUDAMED 8a23bb24-1fc4-4112-94a2-ff58df36242a-2 61 fields · synced Jul 23, 2026