Model G7731D Washer/Disinfector for Dental Instru.
510(k) K884151
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884151 | Date16 May 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LDS
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6991
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device is a washer/disinfector for dental instruments, classified under Device, Pasteurization, Hot Water. It is designed to clean, rinse, and disinfect reusable dental instruments using a combination of hot water and steam pasteurization to ensure high-level disinfection in accordance with regulatory standards. The system is engineered for use in dental practices to maintain instrument sterility between patient use, reducing the risk of cross-contamination.
The Model G7731D is intended for use in dental offices and general hospital settings, operating as a reusable medical device. It is supplied as a standalone unit and requires connection to cold water and electrical power for operation. The device adheres to FDA 510(k) clearance (K884151) under regulation 880.6991, with a classification as a Class II device. It is not single-use and must be maintained according to manufacturer guidelines to ensure proper function and disinfection efficacy.
Questions
AI-generated answers, 20 Sep 2026
What types of dental instruments can the Model G7731D washer/disinfector clean and disinfect, and how does it achieve high-level disinfection?
The Model G7731D is designed for reusable dental instruments commonly used in dental offices and general hospital settings. It achieves high-level disinfection through a combination of hot water and steam pasteurization, following regulatory standards to ensure instruments are thoroughly cleaned, rinsed, and disinfected between patient uses. This process helps reduce the risk of cross-contamination by eliminating pathogens on the instruments.
Is the Model G7731D a single-use device, or is it meant for repeated use in a clinical setting?
The Model G7731D is explicitly designed as a reusable medical device for dental practices and general hospitals. It is not intended for single-use and must be maintained according to the manufacturer’s guidelines to ensure proper function and consistent disinfection efficacy over multiple cycles.
What power and utility connections does the Model G7731D require to operate, and is it a standalone unit?
The Model G7731D operates as a standalone unit but requires connection to both cold water and electrical power to function. These connections are necessary for the device to generate hot water and steam pasteurization for cleaning and disinfecting dental instruments.
What regulatory pathway was followed for FDA clearance of the Model G7731D, and what classification does it hold?
The Model G7731D received FDA clearance through a traditional 510(k) process (K884151) under regulation 880.6991. It is classified as a Class II device, which means it has special controls to ensure its safety and effectiveness, including compliance with performance standards for hot-water pasteurization systems.
How should the Model G7731D be stored when not in use, and are there any specific maintenance requirements?
While the exact storage instructions are manufacturer-specific, the Model G7731D should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. Maintenance requirements include regular cleaning and servicing as outlined in the manufacturer’s guidelines to ensure the device operates correctly and maintains proper disinfection efficacy over time.