Identity
- Trade Name
- TERA HARZ CLEAR FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- TA-28 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- NONE FDA UDI
- Primary DI / UDI-DI
- 08800142100925 FDA UDI
- FDA Product Code
- NXC FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, resin
Tera Harz Clear by Graphy Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Graphy Inc.
Sources (1)
- FDA UDI 103a47d2-9eea-48d4-95e7-9a083e49b019 35 fields · synced Jun 8, 2026