Single Platform SP1 Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232418 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Single Platform SP1 Implant System is a dental implant designed for osseointegrated fixation in the maxilla or mandible. It provides a standardized platform for abutment attachment, enabling stable prosthetic restoration in edentulous or partially edentulous patients. The system incorporates an internal connection mechanism to enhance mechanical stability and long-term integration with the surrounding bone.
This implant system is intended for surgical placement by dental professionals and is supplied sterile for single-use. It is classified under the FDA’s product code DZE (Dental Implants) and has received a Traditional 510(k) clearance. The system is available in various sizes to accommodate different anatomical requirements, with detailed sizing and placement instructions provided in the accompanying surgical guide. Compliance with dental implant standards ensures compatibility with standard prosthetic components and restorative protocols.
Frequently asked questions
What is the Single Platform SP1 Implant System used for?
The Single Platform SP1 Implant System is designed for osseointegrated fixation in the maxilla (upper jaw) or mandible (lower jaw) to support prosthetic restorations in patients who are edentulous (without teeth) or partially edentulous (missing some teeth). Its internal connection mechanism enhances mechanical stability and long-term bone integration, ensuring durable prosthetic attachment.
How is the Single Platform SP1 Implant System supplied?
The system is supplied sterile and intended for single-use only. This ensures optimal hygiene and reduces the risk of infection during surgical placement by dental professionals. Each component adheres to strict sterility protocols to maintain safety and reliability.
Is the Single Platform SP1 Implant System reusable?
No, the Single Platform SP1 Implant System is explicitly designed for single-use. Reusing dental implants can compromise sterility, increase infection risks, and violate manufacturer guidelines. The sterile packaging ensures each implant meets clinical standards for safe, one-time surgical use.
What sizes are available for the Single Platform SP1 Implant System?
The system is available in multiple sizes to accommodate varying anatomical requirements. Detailed sizing information and placement instructions are provided in the accompanying surgical guide, allowing clinicians to select the appropriate implant diameter and length for each patient’s specific needs.
How does the internal connection mechanism benefit the implant system?
The internal connection mechanism in the Single Platform SP1 Implant System improves mechanical stability between the implant and abutment, reducing micromotion and enhancing long-term osseointegration. This design minimizes the risk of loosening or failure over time, supporting more predictable and durable prosthetic outcomes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF CAT-2093-01 Single Platform Implants Product Catalogue, Southern Implants (Pty) Ltd Michelle dos Santos Senior Design ..., PROSTHETIC MANUAL | Southern Implants, K240560 - April Lee - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232418 | Class II | Active |
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Manufacturer
- Manufacturer
- Southern Implants (pty) Ltd
- FDA Applicant
- Southern Implants (Pty), Ltd.
Sources (1)
- FDA 510(k) K232418 24 fields · synced Oct 1, 2026