ITI Dental Implant System
510(k) K010291
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010291 | Date10 May 2001 | 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- Withdrawn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 ITI Dental Implant System is a dental implant device designed for the replacement of missing teeth. Classified under dental implant systems, it integrates with the jawbone to provide a stable foundation for prosthetic teeth, supporting long-term oral function and aesthetics. The system is engineered to facilitate osseointegration, the biological process where bone grows directly onto the implant surface, ensuring durability and biocompatibility. It is intended for use in both single-tooth and multiple-tooth restoration scenarios, adhering to established implantology protocols.
The ITI Dental Implant System is supplied as a sterile, single-use device for surgical placement by qualified dental professionals. It is regulated under the FDA’s 510(k) clearance process, classified under product code DZE for dental implants. The system is intended for use in controlled clinical settings, such as dental offices or oral surgery centers, and requires proper sterilization and handling procedures as per manufacturer guidelines. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the provided data.
Other devices from Straumann USA
Questions
AI-generated answers, 1 Oct 2026
What is the ITI Dental Implant System used for?
The ITI Dental Implant System is designed to replace missing teeth by integrating with the jawbone through osseointegration—a process where bone grows directly onto the implant surface. This provides a stable foundation for prosthetic teeth, supporting both single-tooth and multiple-tooth restorations while ensuring long-term oral function and aesthetics.
How is the ITI Dental Implant System supplied and prepared for use?
The system is supplied as a sterile, single-use device, meaning each implant is intended for one surgical procedure only. It must be handled and placed by qualified dental professionals in controlled clinical settings, such as dental offices or oral surgery centers, following manufacturer guidelines for proper sterilization and surgical protocols.
Is the ITI Dental Implant System reusable, or is it intended for single-use?
The ITI Dental Implant System is explicitly designed for single-use only. This ensures sterility and safety for each patient, as reuse could compromise biocompatibility and infection control standards. The system’s sterile packaging and surgical-grade materials align with this use-case.
What regulatory approval does the ITI Dental Implant System hold?
The ITI Dental Implant System holds FDA 510(k) clearance, classified under product code DZE for dental implants. This clearance confirms it meets regulatory standards for safety and effectiveness as a dental implant system, though no additional approvals beyond this are referenced in the provided data.
Where and how should the ITI Dental Implant System be stored?
The system should be stored in its original sterile packaging until ready for use, following the manufacturer’s instructions to maintain sterility. Storage should occur in a clean, dry environment protected from contamination, extreme temperatures, or direct sunlight. Proper handling before and after opening is critical to preserve its sterile condition.