AP201 Dental X-Ray Film Processor
by Allied Photo Products Co., Inc.
510(k) K900156
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900156 | Date14 May 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 19 Sep 2026
The AP201 Dental X-Ray Film Processor is an automatic radiographic-film processor designed for dental radiology applications. It processes dental X-ray film to produce diagnostic images by chemically developing and fixing exposed film in a controlled, automated process.
This device is intended for single-use film processing in radiology settings and is classified as a Class II medical device under FDA regulations. Supplied as a reusable processor, it requires proper maintenance and adherence to manufacturer guidelines for optimal performance. The AP201 holds an FDA 510(k) clearance (K900156) and is regulated under product code EGY, with no third-party involvement.
Questions
AI-generated answers, 19 Sep 2026
What types of dental X-ray films can the AP201 Dental X-Ray Film Processor handle, and is it designed for specific film sizes or brands?
The AP201 is designed specifically for dental radiographic film processing, but the exact film sizes or brands it supports are not detailed in the provided data. Since it is an automatic processor for dental X-ray film, it is likely compatible with standard intraoral and periapical film sizes commonly used in dental radiology. For precise compatibility, users should refer to the manufacturer’s guidelines or specifications sheet, as the data only confirms its intended use for single-use film processing in dental settings.
Is the AP201 Dental X-Ray Film Processor reusable, and what maintenance is required to keep it functioning properly?
Yes, the AP201 is supplied as a reusable processor. It requires proper maintenance and adherence to the manufacturer’s guidelines to ensure optimal performance. Since it is classified as a reusable device, regular cleaning, chemical replenishment, and potential part replacements (e.g., rollers, belts, or chemical tanks) will be necessary to maintain accuracy and longevity. The manufacturer’s instructions should outline the specific maintenance schedule and procedures.
How is the AP201 Dental X-Ray Film Processor regulated, and what does the FDA clearance indicate about its safety and effectiveness?
The AP201 holds an FDA 510(k) clearance (K900156), which means it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the FDA reviewed it and found it to meet the same safety and effectiveness requirements as the predicate device. The device is classified under product code EGY and falls under the Radiology advisory committee (RA), with no third-party involvement in its regulatory submission.
What is the primary purpose of the AP201 Dental X-Ray Film Processor in a dental clinic setting?
The AP201 is designed for automatic processing of dental X-ray film to produce diagnostic images. It chemically develops and fixes exposed film in a controlled, automated process, ensuring consistent and high-quality radiographic results for dental practitioners. This helps in accurately diagnosing dental conditions such as cavities, gum disease, or bone loss by providing clear and reliable images.