TERA HARZ Hard Denture (THD-C-500) +7 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Graphy Inc.
Identifiers
- 510(k) Number
- K253681 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TERA HARZ Hard Denture is a removable prosthetic dental appliance designed to replace missing teeth and restore oral function. These devices are custom-fitted to restore chewing, speaking, and aesthetic appearance in patients requiring partial or full denture solutions, with variations in hardness and design for specific clinical needs.
Supplied as a reusable dental prosthesis, the TERA HARZ Hard Denture is intended for professional fitting and adjustment by dental practitioners. Each model (THD-C, THD-LP, THD-P, THD-CP) is differentiated by size (500 or 1000) and material properties, with regulatory clearance under FDA 510K and MDD directives. Sterilization and maintenance protocols must follow dental industry standards to ensure patient safety and device longevity.
Frequently asked questions
What are the key differences between the TERA HARZ Hard Denture models, and how do I choose the right one for a patient?
The TERA HARZ Hard Denture models differ by hardness, design, and size (500 or 1000). The THD-C series is standard hardness, while THD-LP offers a lower plasticity for better flexibility. THD-P is designed for partial dentures, and THD-CP combines features of both C and P models. The size (500 or 1000) likely corresponds to patient-specific arch length or volume requirements, determined by the dental practitioner during fitting. Selection depends on clinical needs—hardness for durability, design for partial/full coverage, and size for proper occlusion and comfort.
Are these dentures single-use or reusable, and what maintenance or sterilization steps are required?
The TERA HARZ Hard Denture is designed as a reusable dental prosthesis, intended for long-term use with professional adjustments. Sterilization and maintenance must follow dental industry standards to ensure patient safety and device longevity. This typically includes cleaning with mild detergents, ultrasonic cleaning, and sterilization via autoclave or chemical disinfection as recommended by dental professionals. Avoid harsh chemicals or abrasives that could compromise the material integrity.
How do I verify the regulatory compliance of these dentures before purchasing?
These dentures hold FDA 510K clearance (K253681) and comply with MDD directives, confirming they meet U.S. and European regulatory standards for dental prosthetics. The product code EBI (Dental Prosthetics) further categorizes them for dental use. Always verify the specific lot or batch documentation from Graphy Inc. to confirm compliance with current regulations, as requirements may evolve.
What storage conditions should I follow to preserve the quality of the dentures?
To maintain the integrity of the TERA HARZ Hard Denture, store them in a cool, dry place away from direct sunlight or extreme temperatures. Keep them in their original packaging or a sealed container when not in use. Avoid prolonged exposure to moisture or chemicals, as these can degrade the material over time. Follow manufacturer guidelines for cleaning and storage to ensure durability and patient safety.
Who is the manufacturer contact for technical support or additional information?
For technical support or further details, you can reach Graphy Inc. through their designated contact, Moon-Soo Park, at their Seoul office located at #603,#617 Acegasanforhu 225, Gasan Digital 1-Ro, Geumcheon-Gu, Seoul, 08501, South Korea. Ensure you reference the specific model (e.g., THD-C-500) and batch details when inquiring to receive accurate assistance.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253681 | Class II | Active |
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Manufacturer
- Manufacturer
- Graphy Inc.
- FDA Applicant
- Graphy, Inc.
Sources (2)
- FDA 510(k) K253681 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026