TERA HARZ CLEAR NONE

GUDID 08800142100208

TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent dentition. The TERA HARZ CLEAR is intended for teeth movement by way of continuous gentle force. Fabrication of orthodontic aligner 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: 08800142100208
• NIH Device Record Key: 530c2d69-9ff0-42f6-8068-5553ed84e9de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TERA HARZ CLEAR
• Version Model Number: TC-85DAC
• Catalog Number: NONE
• 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: 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

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
• 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	08800142100208 [Primary]

FDA Product Code

• NXC: Aligner, Sequential

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

On-Brand Devices [TERA HARZ CLEAR]

• 08800142100925: TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent
• 08800142100918: TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent
• 08800142100208: TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent