Hennson International Dental CAD/CAM System
510(k) K904927
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904927 | Date28 Dec 1990 | 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- Withdrawn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
- ELW
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
A computer-assisted design and manufacturing (CAD/CAM) system for dental applications, designed to create and mill dental restorations such as crowns, bridges, and inlays from digital impressions or scans. This system automates the fabrication process, improving precision and efficiency in dental laboratory workflows by converting digital models into physical restorations.
The system is intended for use in dental laboratories and clinics, where it operates as a standalone or integrated solution to produce custom dental prosthetics. Supplied as a reusable device, it requires proper calibration and maintenance to ensure accuracy. Authorized under FDA 510(k) clearance (K904927) as a Class II device under regulation number 872.3660, it adheres to dental industry standards for material compatibility and milling precision. No specific sterility or single-use designation is noted in the regulatory data.
Questions
AI-generated answers, 18 Sep 2026
What types of dental restorations can the Hennson International Dental CAD/CAM System fabricate, and how does it improve workflow efficiency?
The Hennson International Dental CAD/CAM System is designed to create and mill dental restorations such as crowns, bridges, and inlays from digital impressions or scans. It automates the fabrication process by converting digital models into precise physical restorations, significantly improving efficiency and accuracy in dental laboratory workflows. This reduces manual labor and potential human error, streamlining production for dental labs and clinics.
Is the Hennson International Dental CAD/CAM System intended for use in dental labs only, or can it also be integrated into clinic settings?
The system is intended for use in both dental laboratories and clinics, where it operates as a standalone or integrated solution. Its versatility allows it to adapt to different workflow environments, ensuring custom dental prosthetics can be produced efficiently in either setting.
How is the Hennson International Dental CAD/CAM System supplied, and does it require any special handling or maintenance?
The Hennson International Dental CAD/CAM System is supplied as a reusable device, meaning it is not single-use. Proper calibration and regular maintenance are required to ensure its accuracy and longevity, as outlined in the manufacturer’s guidelines. This ensures consistent performance for milling dental restorations.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?
The Hennson International Dental CAD/CAM System received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type, and was determined to be Substantially Equivalent (SESE) to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II medical device under regulation number 872.3660, ensuring it adheres to dental industry standards for material compatibility and milling precision.
Does the system include any specific materials or milling technologies, and how does it ensure precision in fabrication?
While the regulatory data does not specify exact materials or proprietary milling technologies, the system is designed to meet dental industry standards for material compatibility and milling precision. Its precision is achieved through automated CAD/CAM processes that convert digital models into physical restorations with high accuracy, reducing variability in fabrication.