Panoramic X-Ray Units, Modification
FDA 510(k)Class II (US FDA 510(k))
by Planmeca Oy
Identifiers
- 510(k) Number
- K934063 FDA 510(k)
- FDA Product Code
- EHD 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 Panoramic X-Ray Units, Modification is an extraoral x-ray unit with a timer, used in dental applications. It is classified as a class 2 device. The device is designed to capture panoramic x-ray images of the dental structure. The unit is intended for use in a dental setting.
The device is supplied with various registration numbers, including 8043962 and others, and is regulated under regulation number 872.1800. It has been authorized by the FDA under the 510K clearance process, with a decision date of 1993-12-15 and a k-number of K934063. The device is used in a dental setting and is subject to the specified regulations and guidelines.
Frequently asked questions
What is the Panoramic X-Ray Unit Modification used for?
The Panoramic X-Ray Unit Modification is used to capture panoramic x-ray images of the dental structure in a dental setting.
Is the Panoramic X-Ray Unit Modification a single-use or reusable device?
The device description does not specify whether the Panoramic X-Ray Unit Modification is single-use or reusable, but it is classified as a class 2 device.
What regulatory authorizations has the Panoramic X-Ray Unit Modification received?
The Panoramic X-Ray Unit Modification has been authorized by the FDA under the 510K clearance process with a k-number of K934063.
What are the registration numbers associated with the Panoramic X-Ray Unit Modification?
The device is supplied with various registration numbers, including 8043962 and others, and is regulated under regulation number 872.1800.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K934063 | Class II | Active |
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Manufacturer
- Manufacturer
- Planmeca Oy
Sources (1)
- FDA 510(k) K934063 24 fields · synced Sep 23, 2026