NobelClinician DTX Studio Implant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163122 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NobelClinician DTX Studio Implant is a dental X-ray imaging system designed for intraoral and panoramic radiography. It integrates diagnostic imaging with treatment planning software to support dental professionals in assessing bone structure, tooth alignment, and implant site suitability. This system is classified as a Class II medical device under FDA regulations, specifically within the radiology category. Its primary function is to provide high-resolution images for dental diagnostics and guided implant procedures.
This device is supplied as a standalone X-ray system with integrated software for image acquisition, diagnostics, and treatment planning. It is intended for use in dental clinics and oral surgery settings, requiring appropriate training for operation. The system is not single-use; it is designed for reusable clinical applications with standard sterilization protocols for reusable components. The NobelClinician DTX Studio Implant holds FDA 510(k) clearance under K-number K163122, granted in 2017, and is manufactured by Nobel Biocare AB.
Frequently asked questions
What is the NobelClinician DTX Studio Implant used for?
The NobelClinician DTX Studio Implant is a dental X-ray imaging system designed for intraoral and panoramic radiography. It provides high-resolution images to help dental professionals assess bone structure, tooth alignment, and implant site suitability. The integrated software also supports treatment planning for guided implant procedures, making it ideal for dental clinics and oral surgery settings.
How is the NobelClinician DTX Studio Implant supplied?
This device is supplied as a standalone X-ray system that includes integrated software for image acquisition, diagnostics, and treatment planning. It is not a single-use product; instead, it is built for reusable clinical applications in dental settings. Reusable components follow standard sterilization protocols to ensure safety and hygiene.
Is the NobelClinician DTX Studio Implant single-use or reusable?
The NobelClinician DTX Studio Implant is designed for reusable clinical applications. While the system itself is not disposable, reusable components must adhere to standard sterilization protocols to maintain safety and functionality. This ensures long-term use in dental clinics and oral surgery environments.
What regulatory clearance does the NobelClinician DTX Studio Implant hold?
The NobelClinician DTX Studio Implant holds FDA 510(k) clearance under K-number K163122, granted in 2017. It is classified as a Class II medical device under FDA regulations within the radiology category, specifically for dental imaging applications. The clearance was determined through a traditional review process by the Radiology (RA) Advisory Committee.
Where can the NobelClinician DTX Studio Implant be used?
This system is intended for use in dental clinics and oral surgery settings. It requires appropriate training for operation due to its advanced imaging and treatment planning capabilities. The integrated software and high-resolution imaging make it suitable for professionals who need detailed diagnostics and guided implant procedures.
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: DTX Studio™ Clinic | Nobel Biocare, NobelClinician, DTX Studio implant (K163122) — FDA 510 (k) | Innolitics, Nobel Biocare Ab NobelClinician, DTX Studio Implant
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163122 | Class II | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
Sources (1)
- FDA 510(k) K163122 24 fields · synced Oct 6, 2026