Straumann Computer Aided Restoration Service
510(k) K052272
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052272 | Date3 Jan 2006 | 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- Withdrawn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
- NHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Straumann Computer Aided Restoration Service is a dental computer-aided design and manufacturing (CAD/CAM) system for creating implant abutments and prosthetic components. Classified under the Dental, Endosseous Implant Abutment category (NHA), it facilitates precise fabrication of custom dental restorations using digital planning and milling technology. This system supports the integration of implantology with restorative dentistry, ensuring accurate fit and function for patient-specific solutions. It is designed to enhance workflow efficiency in dental practices by combining digital imaging with automated manufacturing processes.
This service is supplied as a software-driven workflow integrated with Straumann’s implant systems, requiring compatible hardware and milling units for physical production. It is intended for use in dental laboratories and clinics equipped with CAD/CAM technology, where sterility and precision are maintained through controlled manufacturing environments. The system is FDA-cleared under 510(k) K052272 as substantially equivalent to a predicate device, adhering to dental implant abutment standards. No single-use or reusable classification is specified; functionality depends on the associated hardware and software compatibility.
Other devices from Straumann USA
Questions
AI-generated answers, 1 Oct 2026
What is the Straumann Computer Aided Restoration Service used for?
The Straumann Computer Aided Restoration Service is a dental CAD/CAM system designed specifically for creating implant abutments and prosthetic components. It combines digital imaging and automated milling to produce custom dental restorations tailored to individual patients, ensuring precise fit and function. This integration of implantology and restorative dentistry enhances workflow efficiency in dental labs and clinics equipped with compatible hardware.
How is the Straumann Computer Aided Restoration Service supplied and what hardware is required?
This service is supplied as a software-driven workflow that integrates with Straumann’s implant systems. To function, it requires compatible hardware, including milling units for physical production of the abutments or restorations. The system relies on existing CAD/CAM technology in dental labs or clinics to execute the digital planning and automated manufacturing processes.
Is the Straumann Computer Aided Restoration Service single-use or reusable?
The Straumann Computer Aided Restoration Service itself is not classified as single-use or reusable; its functionality depends on the associated hardware and software compatibility. The physical components produced (e.g., abutments) are typically single-use, while the software and milling units are designed for repeated use in controlled environments where sterility and precision are maintained.
What regulatory clearance does the Straumann Computer Aided Restoration Service hold?
The Straumann Computer Aided Restoration Service holds FDA clearance under the 510(k) pathway, specifically clearance number K052272. It was determined to be substantially equivalent to a predicate device and falls under the Dental, Endosseous Implant Abutment category (NHA). The clearance was granted in 2006, adhering to dental implant abutment standards.
Where can the Straumann Computer Aided Restoration Service be used?
This service is intended for use in dental laboratories and clinics equipped with CAD/CAM technology. The workflow requires a controlled environment where digital planning and milling can be performed with precision and sterility. It is designed to streamline the fabrication of custom implant restorations, ensuring compatibility with Straumann’s implant systems.