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TERA HARZ II

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233502

by Graphy Inc.

Identifiers

510(k) Number
K233502 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TERA HARZ II is a dental radiography device, specifically a digital panoramic X-ray system designed for capturing comprehensive images of the maxillofacial region. It employs advanced imaging technology to provide high-resolution, two-dimensional views of the teeth, jaws, nasal, and sinus areas, aiding in diagnostic evaluations for dental and orthodontic assessments.

This device is intended for use in dental clinics and oral healthcare settings, where it is operated by trained professionals to acquire panoramic radiographs. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure consistent imaging quality. Authorized under FDA 510K and MDD compliance, the TERA HARZ II adheres to regulatory standards for dental radiography equipment, ensuring safety and performance in clinical environments.

Frequently asked questions

What types of dental and maxillofacial images can the TERA HARZ II capture, and how does this benefit clinical assessments?

The TERA HARZ II is a digital panoramic X-ray system that captures high-resolution, two-dimensional images of the entire maxillofacial region, including teeth, jaws, nasal cavities, and sinuses. This comprehensive view aids clinicians in diagnosing dental issues, planning orthodontic treatments, evaluating wisdom teeth, and assessing bone structure—all in a single scan, reducing the need for multiple exposures and improving diagnostic accuracy.

Is the TERA HARZ II designed for single-use or repeated use in clinical settings, and what maintenance is required?

The TERA HARZ II is supplied as a reusable medical instrument, meaning it is intended for repeated use in dental clinics after proper cleaning, disinfection, and maintenance. To ensure consistent imaging quality and safety, it requires regular calibration and upkeep as outlined in the manufacturer’s guidelines, which are critical for maintaining regulatory compliance and performance standards.

How is the TERA HARZ II regulated, and what does this mean for healthcare providers using the device?

The TERA HARZ II is authorized under FDA 510K clearance and MDD (Medical Device Directive) compliance, confirming it meets regulatory standards for dental radiography equipment in the U.S. and EU markets. This means healthcare providers can rely on its safety, performance, and adherence to established guidelines for panoramic X-ray imaging, though local regulations (e.g., radiation safety protocols) must still be followed.

Does the TERA HARZ II come in different sizes or models, and if so, how might this affect its clinical application?

The provided specifications do not list variations in sizes or models for the TERA HARZ II, suggesting it is offered as a single, standardized panoramic X-ray system. This design ensures consistency in imaging quality and ease of use across dental clinics, though clinicians should verify compatibility with their facility’s spatial and operational requirements before installation.

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

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Graphy Inc.
FDA Applicant
Graphy, Inc.

Sources (2)

  • FDA 510(k) K233502 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026