Tera Harz Clear Aligner
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Graphy Inc.
Identity
- Trade Name
- TERA HARZ CLEAR EUDAMED
- Device Name
- TERA HARZ CLEAR EUDAMED
- Model / Reference
- TC-85DAW EUDAMEDnone EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800142100215 EUDAMED
- Basic UDI-DI
- B-08800142100215 EUDAMED
- 510(k) Number
- K223355 FDA 510(k)
- FDA Product Code
- NXC FDA 510(k)
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5470 FDA 510(k)
- Regulation Number
- 872.5470 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Tera Harz Clear Aligner is a dental device classified as a sequential aligner, designed for orthodontic treatment to gradually reposition teeth. It is constructed from clear thermoplastic material to provide a discreet and removable option for correcting dental alignment, suitable for both adult and adolescent patients.
These aligners are supplied as a series of custom-fitted trays, each worn sequentially to apply controlled force to teeth over time. They are intended for single-patient use and are regulated under FDA 510(k) clearance, MDD, and MDR compliance. The device is non-reusable, non-sterile, and must be stored in a clean, dry environment as per manufacturer instructions. Multiple reference codes (e.g., 3008882689, 1000118628) correspond to specific aligner sets, ensuring traceability and compliance with dental orthodontic standards.
Frequently asked questions
What is the Tera Harz Clear Aligner used for?
The Tera Harz Clear Aligner is a dental device designed for orthodontic treatment to gradually reposition teeth. It is a sequential aligner made from clear thermoplastic material, providing a discreet and removable option for correcting dental alignment in both adult and adolescent patients.
How are the Tera Harz Clear Aligners supplied?
The aligners are supplied as a series of custom-fitted trays, each worn sequentially to apply controlled force to teeth over time. Multiple reference codes correspond to specific aligner sets, ensuring traceability and compliance with dental orthodontic standards.
Are the Tera Harz Clear Aligners reusable or sterile?
The Tera Harz Clear Aligners are intended for single-patient use and are non-reusable. They are non-sterile and must be stored in a clean, dry environment as per manufacturer instructions.
What regulatory approvals does the Tera Harz Clear Aligner have?
The Tera Harz Clear Aligner is regulated under FDA 510(k) clearance, MDD, and MDR compliance. It is classified as a Class II device with product code NXC and has received clearance through the traditional pathway.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223355 | Class II | Active |
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Manufacturer
- Manufacturer
- Graphy Inc.
- FDA Applicant
- Graphy, Inc.
Sources (2)
- FDA 510(k) K223355 24 fields · synced Sep 18, 2026
- EUDAMED f19818b2-a1b1-4b16-9b9d-74b6625c5188 61 fields · synced Jul 25, 2026