S.I.N. Dental Implant System
by S.I.N. Implant System Ltda 3 variants
510(k) K251262
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251262 | Date26 Sep 2025 | 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- Withdrawn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 S.I.N. Dental Implant System is a dental implant device designed for osseointegrated restoration of missing teeth. It is classified under dental implant systems and is intended for use in oral and maxillofacial surgery to support prosthetic replacements, including full-arch solutions. The system includes components for abutments and implant fixtures, enabling stable integration with the jawbone for long-term dental restoration.
This system is supplied as a sterile, single-use implant kit and is regulated under FDA 510(k) clearance (K251262) as substantially equivalent to predicate devices. It is intended for use in clinical settings by trained dental professionals, adhering to standard implantology protocols. The system is not MRI-safe, and proper handling, storage, and sterilisation procedures must be followed as per manufacturer guidelines. No additional regulatory approvals beyond the stated 510(k) clearance are implied.
Other devices from S.I.N. Implant System Ltda
Questions
AI-generated answers, 1 Oct 2026
What is the S.I.N. Dental Implant System used for?
The S.I.N. Dental Implant System is designed for osseointegrated restoration of missing teeth in oral and maxillofacial surgery. It provides stable support for prosthetic replacements, including full-arch solutions, by integrating with the jawbone to ensure long-term dental stability. This system is specifically engineered to meet clinical needs for durable implant fixtures and abutments.
Is the S.I.N. Dental Implant System sterile and single-use?
Yes, the S.I.N. Dental Implant System is supplied as a sterile, single-use implant kit. Sterility ensures patient safety by preventing cross-contamination, while single-use design eliminates the need for reprocessing, reducing infection risks and maintaining consistent performance for each procedure.
What regulatory clearance does the S.I.N. Dental Implant System hold?
The system holds FDA 510(k) clearance under the reference number K251262, classified as substantially equivalent to predicate devices. This clearance confirms that the system meets U.S. regulatory standards for safety and effectiveness in dental implant applications, though it does not imply additional approvals beyond this specific filing.
Can the S.I.N. Dental Implant System be used with MRI scans?
No, the S.I.N. Dental Implant System is not MRI-safe. Patients with this system should avoid MRI procedures, as the metallic components could pose risks such as heating or displacement during imaging. Clinicians must inform patients of this limitation and follow alternative diagnostic protocols when necessary.
How should the S.I.N. Dental Implant System be stored?
The system must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping the sterile packaging intact, storing in a clean, dry environment away from direct sunlight or extreme temperatures, and adhering to expiration dates. Proper storage ensures the integrity of the implant components for clinical use.