Smith S-100 Time & Temperature Control
by Smith Companies Dental Products
510(k) K955825
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955825 | Date5 Apr 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 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- Withdrawn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, 1 Oct 2026
The Smith S-100 Time and Temperature Control is an Automatic Processor for Radiographic Film, Dental, classified under FDA regulation 892.1900. This device processes dental radiographic film by controlling exposure time and temperature to ensure consistent development, facilitating accurate radiographic imaging in dental radiology settings. It is designed to automate the film processing workflow, reducing manual intervention and improving efficiency in dental clinics.
This device is supplied as a reusable Class II medical instrument, intended for use in dental radiology environments. It operates under controlled conditions to maintain precise temperature and timing parameters, ensuring optimal film development. The Smith S-100 adheres to FDA clearance (510(k) K955825) and is regulated under the Radiology advisory committee, with no third-party certification indicated. Storage and maintenance instructions are manufacturer-specific but typically require adherence to standard medical device hygiene protocols.
Questions
AI-generated answers, 1 Oct 2026
What is the Smith S-100 Time & Temperature Control used for?
The Smith S-100 is an automatic processor designed specifically for dental radiographic film. It controls exposure time and temperature to ensure consistent and accurate film development, which is critical for clear radiographic imaging in dental clinics. By automating the workflow, it reduces manual handling errors and improves efficiency in processing dental X-rays.
Is the Smith S-100 a single-use or reusable device?
The Smith S-100 is a reusable Class II medical instrument. As a reusable device, it must be maintained and cleaned according to manufacturer guidelines to ensure proper functionality and hygiene, adhering to standard medical device hygiene protocols.
What regulatory approval does the Smith S-100 have?
The Smith S-100 holds FDA 510(k) clearance under the classification of an Automatic Processor for Radiographic Film, Dental. It was determined to be substantially equivalent to a predicate device and is regulated under the Radiology advisory committee. The clearance number is K955825.
How does the Smith S-100 ensure consistent radiographic imaging?
The device achieves consistent radiographic imaging by precisely controlling both time and temperature during the film processing cycle. This automation eliminates variability caused by manual adjustments, ensuring that each film develops uniformly under optimal conditions, which is essential for accurate diagnostic imaging in dental practice.
What are the storage and maintenance requirements for the Smith S-100?
While specific storage and maintenance instructions are manufacturer-provided, reusable medical devices like the Smith S-100 generally require adherence to standard hygiene protocols. This includes regular cleaning, disinfection, and calibration checks to maintain performance and prevent contamination. Always follow the manufacturer’s guidelines to ensure proper operation and longevity of the device.