FDA UDI
In Commercial Distribution
🇺🇸 United States
TERA HARZ
DI: 08800142100123
·
Model: TC-80DPA3
·
Graphy Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TERA HARZ
- Primary DI
- 08800142100123
- Version / Model
- TC-80DPA3
- Catalog Number
- NONE
- Company Name
- Graphy Inc.
- Labeler DUNS
- 694827880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-09
- Public Version
- 1
- Public Version Date
- 2024-05-17
- Public Version Status
- New
- Public Device Record Key
- fdb87a73-93ae-4e64-954e-cdbfffb67c1f
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38781 | Dental prosthesis veneer resin | A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800142100123 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202846 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit