FDA UDI
In Commercial Distribution
🇺🇸 United States
TERA HARZ CLEAR
DI: 08800142100925
·
Model: TA-28
·
Graphy Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TERA HARZ CLEAR
- Primary DI
- 08800142100925
- Version / Model
- TA-28
- 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
- 2
- Public Version Date
- 2026-03-27
- Public Version Status
- Update
- Public Device Record Key
- 103a47d2-9eea-48d4-95e7-9a083e49b019
Device Description
TERA HARZ CLEAR is available in two forms: (1) a light-curable, methacrylate-based photopolymer resin (marketed as "Tera Harz Clear") intended for the fabrication of orthodontic aligners; and (2) a finished device form, a clear orthodontic aligner (marketed as "Shape Memory Aligner"), manufactured from the resin. The finished aligner is intended for the correction of dental malocclusion in patients with permanent dentition by applying continuous gentle force to move teeth.
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 |
|---|---|---|---|---|
| NXC | Aligner, Sequential | Dental | 872.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16730 | Dental appliance fabrication material, resin | A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800142100925 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit