SCAN300FP Retropan (VDC)
by Oy Ajat, Ltd. 510(k)
Active
510(k) K051664
Overview
The Scan300FP Retropan (VDC) is a digital extraoral X-ray system designed for dental imaging. It functions as a conversion kit that replaces conventional radiographic film by capturing X-ray signals from oral tissues and teeth, converting them into instant digital images for diagnostic evaluation. This device is classified as an X-ray system, specifically an extraoral source with digital imaging capabilities, tailored for dental applications.
The Scan300FP Retropan (VDC) is supplied as a reusable digital conversion kit, intended for use in dental offices. It connects to a compatible dental imaging system, such as DentalEye, to process and display images. The device has received FDA 510(k) clearance under the Traditional review pathway, with a classification of Class II (MUH product code). It is not specified as MRI-safe or single-use, and no sterility requirements are indicated in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051664 | Date20 Jul 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MUH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Scan300FP Retropan (VDC) used for?
The Scan300FP Retropan (VDC) is a digital conversion kit designed specifically for dental extraoral X-ray imaging. It replaces traditional radiographic film by capturing X-ray signals from oral tissues and teeth, converting them into digital images for immediate diagnostic evaluation. This eliminates the need for film processing and provides faster, more efficient imaging for dentists.
How is the Scan300FP Retropan (VDC) supplied and used?
The Scan300FP Retropan (VDC) is supplied as a reusable conversion kit. It connects to a compatible dental imaging system, such as DentalEye, to process and display the captured X-ray images. The device is not intended for standalone use but rather as an add-on to existing dental X-ray systems, enabling digital imaging capabilities where they previously relied on film.
Is the Scan300FP Retropan (VDC) single-use or reusable?
The Scan300FP Retropan (VDC) is explicitly designed as a reusable device. Unlike single-use items, it is intended for repeated use in dental offices, provided it is properly maintained and cleaned according to manufacturer guidelines. This makes it a cost-effective solution for practices looking to transition from film-based to digital imaging.
Does the Scan300FP Retropan (VDC) require sterilization?
The regulatory data for the Scan300FP Retropan (VDC) does not specify any sterility requirements. Since it is a reusable conversion kit for dental imaging, it should be handled in accordance with standard infection control practices for medical devices. This typically includes cleaning and disinfection between uses, though the exact protocol would be outlined in the manufacturer’s instructions for use.
What regulatory pathway was followed for the Scan300FP Retropan (VDC)?
The Scan300FP Retropan (VDC) received FDA 510(k) clearance under the Traditional review pathway. It is classified as a Class II medical device under the MUH (Mouth, Head) product code. This classification indicates that the device is considered to present a low to moderate risk and requires pre-market notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.