Model 410 Dental X-Ray Film Processors
by Dent-X Co. 510(k)
Active
510(k) K874118
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874118 | Date6 Nov 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EGY
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1900
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Model 410 Dental X-Ray Film Processors is an Automatic Processor, Radiographic-Film, Dental (per FDA classification EGY). This device is designed to develop and process dental radiographic film, enabling the production of clear radiographic images for diagnostic purposes in dentistry. It automates the chemical processing steps required to reveal latent images on exposed film, ensuring consistent and efficient development.
These processors are intended for use in radiology settings, such as dental clinics and offices, where dental radiographs are routinely taken. Supplied as a reusable Class II medical device, the Model 410 adheres to FDA regulatory standards, having received FDA 510(k) clearance under K-number K874118 in 1987. No specific sterility or single-use designation is noted in the regulatory data, though standard cleaning and maintenance protocols would apply to ensure proper function and hygiene.
Questions
AI-generated answers, 1 Oct 2026
What is the Model 410 Dental X-Ray Film Processor used for?
The Model 410 Dental X-Ray Film Processor automates the chemical development of dental radiographic film, producing clear and consistent radiographic images for diagnostic purposes in dental settings. It handles the full processing cycle—including development, fixation, and washing—ensuring reliable results for intraoral and extraoral dental radiographs.
Is the Model 410 a single-use or reusable device?
The Model 410 is designed as a reusable Class II medical device. While no explicit sterility designation is provided, standard cleaning and maintenance protocols are required to maintain hygiene and functionality. Regular upkeep ensures prolonged use in clinical environments.
What regulatory approval does the Model 410 hold?
The Model 410 received FDA 510(k) clearance under K-number K874118 in 1987, classified as substantially equivalent under the traditional review pathway. It adheres to FDA regulatory standards for automatic radiographic-film processors in dentistry.
How is the Model 410 supplied and maintained?
The processor is supplied as a complete unit for installation in dental clinics or radiology settings. Maintenance involves routine cleaning of chemical tanks, rollers, and transport mechanisms to prevent film artifacts and ensure optimal image quality. Manufacturer guidelines should be followed for chemical replenishment and equipment calibration.
Does the Model 410 support different film sizes or models?
The Model 410 is designed to process standard dental radiographic film sizes used in intraoral and extraoral imaging. While specifications do not list explicit model variations, its automated design accommodates common film formats (e.g., periapical, bitewing, panoramic). Compatibility may depend on film dimensions and processor rollers, so verifying film type with the manufacturer is recommended.