Tera Harz Guard

GUDID 08800142100949

TERA HARZ GUARD is designed to assist the dentist in prescribing a device to prevent a patient from grinding their teeth. The production of final devices in the dental clinic requires a computer-aided design and manufacturing (CAD/CAM) system, which includes the following: intraoral scanner, design software, additive 3D printer (DLP/SLA/LCD), and post curing unit.

Graphy Inc.

Dental appliance fabrication material, resin

• Primary Device ID: 08800142100949
• NIH Device Record Key: 86898d10-c1d3-4d78-9b93-41c5823a9c36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tera Harz Guard
• Version Model Number: TE-151
• 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: true
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800142100949 [Primary]

FDA Product Code

• BRW: Protector, Dental

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: 2025-07-28
• Device Publish Date: 2025-07-18

Devices Manufactured by Graphy Inc.

• 08800142100949 - Tera Harz Guard: 2025-07-28TERA HARZ GUARD is designed to assist the dentist in prescribing a device to prevent a patient from grinding their teeth. The production of final devices in the dental clinic requires a computer-aided design and manufacturing (CAD/CAM) system, which includes the following: intraoral scanner, design software, additive 3D printer (DLP/SLA/LCD), and post curing unit.
• 08800142100949 - Tera Harz Guard: 2025-07-28 TERA HARZ GUARD is designed to assist the dentist in prescribing a device to prevent a patient from grinding their teeth. The pr
• 08800142100109 - TERA HARZ: 2024-05-17 TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The
• 08800142100116 - TERA HARZ: 2024-05-17 TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The
• 08800142100123 - TERA HARZ: 2024-05-17 TERA HARZ is a monomer as a biocompatible material based on Acrylic esters indicated for manufacturing of all types of preformed
• 08800142100208 - TERA HARZ CLEAR: 2024-05-17 TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent dentition. The TERA HARZ CLEAR
• 08800142100307 - TERA HARZ SG: 2024-05-17 TERA HARZ SG are intended to support the dentist or oral surgeon when drilling for placement of dental implants. Fabrication of
• 08800142100499 - TERA HARZ DENTURE: 2024-05-17 The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and b
• 08800142100512 - TERA HARZ DENTURE: 2024-05-17 The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and b