TERA HARZ HARD DENTURE

GUDID 08800142100444

The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.

Graphy Inc.

Dental appliance fabrication material, resin

• Primary Device ID: 08800142100444
• NIH Device Record Key: 5ad9a683-e62d-442e-b1f0-092b3aad4b06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TERA HARZ HARD DENTURE
• Version Model Number: THD-P-500
• Company DUNS: 694827880
• Company Name: Graphy Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800142100444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253681

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03

On-Brand Devices [TERA HARZ HARD DENTURE]

• 08800142100475: The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive
• 08800142100468: The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive
• 08800142100451: The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive
• 08800142100444: The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive
• 08800142100437: The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive
• 08800142100420: The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive
• 08800142100413: The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive
• 08800142100406: The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive