FDA UDI
In Commercial Distribution
🇺🇸 United States
Tera Harz Guard
DI: 08800142100949
·
Model: TE-151
·
Graphy Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tera Harz Guard
- Primary DI
- 08800142100949
- Version / Model
- TE-151
- Company Name
- Graphy Inc.
- Labeler DUNS
- 694827880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-18
- Public Version
- 1
- Public Version Date
- 2025-07-28
- Public Version Status
- New
- Public Device Record Key
- 86898d10-c1d3-4d78-9b93-41c5823a9c36
Device Description
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.
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| BRW | Protector, Dental | Anesthesiology | 868.5820 | 1 |
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 | 08800142100949 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit