Straumann Dental Implant System
by Straumann USA, LLC 3 variants
510(k) K123784
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123784 | Date10 Apr 2013 | 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- Withdrawn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
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Straumann Dental Implant System is a dental implant device designed for the replacement of missing teeth. It is classified as a dental implant under the FDA’s Product Code DZE, intended for osseointegrated fixation in the jawbone to support prosthetic restorations. The system is engineered to provide stable, long-term support for crowns, bridges, or dentures, facilitating natural tooth function and aesthetics. Its design emphasizes precision and biocompatibility to ensure integration with the patient’s bone structure.
This system is supplied as a sterile, single-use implant intended for surgical placement by dental professionals in clinical settings. It is available in various sizes and configurations to accommodate different anatomical requirements. The device is regulated under FDA 510(k) clearance (K123784) and adheres to dental implant standards for safety and efficacy. Storage and handling follow sterile medical device protocols to maintain integrity before use.
Other devices from Straumann USA
Questions
AI-generated answers, 1 Oct 2026
What is the Straumann Dental Implant System used for?
The Straumann Dental Implant System is designed to replace missing teeth by providing osseointegrated fixation in the jawbone. This allows for stable support of prosthetic restorations such as crowns, bridges, or dentures, restoring natural tooth function and aesthetics. Its precision engineering ensures compatibility with the patient’s bone structure for long-term stability.
How is the Straumann Dental Implant System supplied and prepared for use?
The system is supplied as a sterile, single-use implant, ensuring safety and sterility for surgical placement by dental professionals. It is intended exclusively for clinical use and must be handled according to sterile medical device protocols to maintain its integrity before implantation.
Are there different sizes or configurations available for this implant system?
Yes, the Straumann Dental Implant System is available in various sizes and configurations to accommodate different anatomical requirements. This versatility allows dental professionals to select the most appropriate implant for each patient’s specific needs, ensuring optimal fit and function.
Is the Straumann Dental Implant System reusable or single-use?
The Straumann Dental Implant System is designed for single-use only. This ensures sterility and safety, as reuse could compromise the device’s integrity and risk infection or complications during implantation.
What storage and handling guidelines should be followed for this implant system?
The Straumann Dental Implant System must be stored and handled following strict sterile medical device protocols. This includes maintaining the sterile packaging until immediate use, protecting the device from contamination, and adhering to manufacturer-recommended storage conditions to preserve its integrity and functionality.