TERA HARZ NONE

GUDID 08800142100123

TERA HARZ is a monomer as a biocompatible material based on Acrylic esters indicated for manufacturing of all types of preformed crown and bridge bases in dental laboratories. Fabrication of these prostheses require a manufacturing of all laser and DLP based 3D printers.

Graphy Inc.

Dental prosthesis veneer resin

• Primary Device ID: 08800142100123
• NIH Device Record Key: fdb87a73-93ae-4e64-954e-cdbfffb67c1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TERA HARZ
• Version Model Number: TC-80DPA3
• 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	08800142100123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202846

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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]

• 08800142100123: TERA HARZ is a monomer as a biocompatible material based on Acrylic esters indicated for manufac
• 08800142100116: TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations,
• 08800142100109: TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations,