ScanX Swift 2.0, ScanX Swift View 2.0
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230095 FDA 510(k)
- FDA Product Code
- MUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ScanX Swift 2.0 and ScanX Swift View 2.0 are digital X-ray systems designed for dental imaging. These systems utilize extraoral X-ray sources to capture digital images, providing diagnostic capabilities in dental practices.
The device is supplied as a compact, single-slot in-operatory solution and is compatible with thin, flexible, wireless IDX PSPs. It is a Class II medical device with FDA 510(k) clearance, registered under product code MUH, and is manufactured by DÜRR DENTAL SE in Bietigheim-Bissingen, Germany.
Frequently asked questions
What is the ScanX Swift 2.0 used for in dental practices?
The ScanX Swift 2.0 and ScanX Swift View 2.0 are digital X-ray systems designed for dental imaging, utilizing extraoral X-ray sources to capture digital images for diagnostic purposes in dental practices.
How is the ScanX Swift 2.0 supplied and what are its compatibility features?
The device is supplied as a compact, single-slot in-operatory solution and is compatible with thin, flexible, wireless IDX PSPs, making it convenient for dental imaging workflows.
What is the regulatory status of the ScanX Swift 2.0?
The ScanX Swift 2.0 is a Class II medical device with FDA 510(k) clearance, registered under product code MUH, and manufactured by DÜRR DENTAL SE in Bietigheim-Bissingen, Germany.
Can the ScanX Swift 2.0 be reused or is it single-use?
The device is designed for repeated use in dental practices as part of a digital imaging system, not as a disposable single-use item, though the compatible PSPs may be single-use depending on the type selected.
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: ScanX Swift View 2.0 - Air Techniques, ScanX Swift View 2.0 | Henry Schein Catalog, ScanX Swift View 2.0 Phosphorous Plate Scanner, ScanX Swift View 2.0 | Medline Sinclair Dental
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230095 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dürr Dental Se
- FDA Applicant
- Durr Dental SE
Sources (1)
- FDA 510(k) K230095 24 fields · synced Oct 1, 2026