Identifiers
- 510(k) Number
- K161652 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Diazir is a dental device classified under product code EIH, designed for intraoral use in restorative and prosthetic dentistry. It is intended for applications requiring precise material handling, such as the preparation or application of dental ceramics or composites in fixed prosthodontics. The device is engineered to support high-performance dental workflows, ensuring accuracy and efficiency in clinical procedures.
Diazir is supplied as a reusable instrument, intended for use in dental clinics and laboratories. It is not sterile upon delivery and must be cleaned, disinfected, and sterilized between uses in accordance with standard dental infection control protocols. The device is not labeled as MRI-safe or unsafe, and its dimensions or specific handling instructions are not detailed in the provided data. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K161652), it adheres to regulatory standards for dental instruments.
Frequently asked questions
What is the Diazir dental instrument used for?
The Diazir is designed for intraoral use in restorative and prosthetic dentistry, specifically for applications requiring precise material handling. This includes the preparation or application of dental ceramics or composites in fixed prosthodontics, helping clinicians achieve accuracy and efficiency during procedures.
Is the Diazir supplied sterile, and how should it be prepared for use?
The Diazir is not sterile upon delivery. It must be cleaned, disinfected, and sterilized between uses following standard dental infection control protocols to ensure safety and compliance with clinical standards.
Can the Diazir be reused, or is it intended for single-use?
The Diazir is explicitly designed as a reusable instrument. It is intended for use in dental clinics and laboratories, with proper cleaning, disinfection, and sterilization required between patient or material applications to maintain hygiene and functionality.
Does the Diazir have any specific MRI safety information?
The provided data does not specify whether the Diazir is MRI-safe or MRI-unsafe. Clinicians should verify compatibility with their facility’s MRI protocols before use if MRI imaging is required for the patient.
What regulatory clearance does the Diazir hold, and where is it authorized?
The Diazir holds FDA 510(k) clearance (K161652) and is authorized for commercial distribution in the United States. This clearance indicates it meets regulatory standards for dental instruments under the product code EIH, ensuring its safety and effectiveness for the intended use.
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. Sources consulted: Zxtgy (Beijing)Technology Co.,Ltd - Made-in-China.com, Zxtgy (Beijing) Technology Co., Ltd. FDA 510(k) Products (2017-2017), K161652 FDA 510 (k) - DIAZIR, Zxtgy (Beijing) Technology Co.,Ltd ,China - company-listing.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161652 | Class II | Active |
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Manufacturer
- Manufacturer
- Zxtgy (Beijing) Technology Co., Ltd.
Sources (1)
- FDA 510(k) K161652 24 fields · synced Oct 5, 2026