TERA HARZ SG NONE

GUDID 08800142100307

TERA HARZ SG are intended to support the dentist or oral surgeon when drilling for placement of dental implants. Fabrication of surgical guide in dental Hospital requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

Graphy Inc.

Dental appliance fabrication material, resin

• Primary Device ID: 08800142100307
• NIH Device Record Key: 06e7f124-7e92-4128-a087-7c38495f2aca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TERA HARZ SG
• Version Model Number: SG-100
• Catalog Number: NONE
• Company DUNS: 694827880
• Company Name: Graphy Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800142100307 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

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: 2024-05-17
• Device Publish Date: 2024-05-09

Devices Manufactured by Graphy Inc.

• 08800142100406 - TERA HARZ HARD DENTURE: 2025-12-11 The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing den
• 08800142100413 - TERA HARZ HARD DENTURE: 2025-12-11 The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing den
• 08800142100420 - TERA HARZ HARD DENTURE: 2025-12-11 The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing den
• 08800142100437 - TERA HARZ HARD DENTURE: 2025-12-11 The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing den
• 08800142100444 - TERA HARZ HARD DENTURE: 2025-12-11 The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing den
• 08800142100451 - TERA HARZ HARD DENTURE: 2025-12-11 The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing den
• 08800142100468 - TERA HARZ HARD DENTURE: 2025-12-11 The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing den
• 08800142100475 - TERA HARZ HARD DENTURE: 2025-12-11 The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing den