Saturno Overdenture Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133327 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 Saturno Overdenture Implant System is a dental implant designed for retaining overdentures or partial dentures in the mandible or maxilla. It is classified as a dental implant attachment system, featuring a one-piece, self-tapping, threaded design with a pivoting O-Ball connection for enhanced stability and minimal profile.
This system is intended for use in dental practices to restore masticatory function, with potential for immediate loading in suitable cases. Supplied as a sterile, single-use device, it is available in straight or angled configurations and is regulated under FDA 510(k) clearance (K133327). Compliance with dental implant standards ensures compatibility with standard overdenture frameworks.
Frequently asked questions
What types of dental restorations is the Saturno Overdenture Implant System designed to support, and how does its design improve stability for patients?
The Saturno Overdenture Implant System is specifically designed to retain overdentures or partial dentures in either the mandible (lower jaw) or maxilla (upper jaw). Its one-piece, self-tapping, threaded design ensures secure placement in bone, while the pivoting O-Ball connection reduces friction and minimizes the profile, enhancing stability and comfort for patients. This design is particularly useful for restoring masticatory (chewing) function, with the potential for immediate loading in appropriate clinical cases.
Is the Saturno Overdenture Implant System intended for reuse, or is it meant to be used only once per patient? How does this affect clinical workflow?
The Saturno Overdenture Implant System is supplied as a sterile, single-use device, meaning each implant is intended for one patient only. This design choice simplifies clinical workflow by eliminating the need for sterilization between uses, reducing the risk of cross-contamination, and ensuring consistent performance. Clinicians can proceed directly with placement without additional preparation steps.
What configurations are available for the Saturno Overdenture Implant System, and how might this flexibility benefit different patients?
The system is available in straight and angled configurations, allowing clinicians to tailor the implant’s orientation to the patient’s anatomy. This flexibility is particularly useful for addressing variations in jaw structure or alignment, ensuring optimal positioning for overdenture retention and improved stability. Angled implants can help navigate challenging anatomical barriers, while straight implants may be preferred for simpler cases.
How should the Saturno Overdenture Implant System be stored, and what precautions should be taken to maintain its sterility before use?
Since the system is supplied as a sterile, single-use device, it should be stored in its original, unopened packaging until ready for use. The packaging is designed to preserve sterility, so it should remain intact and protected from contamination (e.g., moisture, dust, or physical damage) until implantation. Clinicians should follow manufacturer guidelines for handling to avoid compromising sterility before insertion.
What regulatory pathway does the Saturno Overdenture Implant System follow, and what does this mean for clinicians considering its use?
The Saturno Overdenture Implant System is regulated under the FDA 510(k) clearance process, specifically classified under product code DZE (Dental Implant Attachment System) and reviewed by the Dental (DE) Advisory Committee. Its clearance (K133327) as substantially equivalent to a predicate device means it meets FDA standards for safety and effectiveness. Clinicians can rely on this regulatory pathway as evidence of the system’s compliance with dental implant standards, ensuring compatibility with standard overdenture frameworks.
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: SATURNO (TM) OVERDENTURE IMPLANT SYSTEM by ZEST ANCHORS, LLC | FDA 510 ..., SATURNO® Narrow Diameter Implant System - Zest Dent, SATURNO (TM) OVERDENTURE IMPLANT SYSTEM (K133327) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133327 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (1)
- FDA 510(k) K133327 24 fields · synced Sep 18, 2026