Syntec Orthodontic Mini Screw Extended System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202790 FDA 510(k)
- FDA Product Code
- OAT 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 Syntec Orthodontic Mini Screw Extended System is an Implant, Endosseous, Orthodontic device, classified under FDA Product Code OAT. These devices are designed for skeletal anchorage in orthodontic treatment, providing stable fixation points for tooth movement without relying on patient cooperation. The system is intended for insertion into bone to support orthodontic appliances, aiding in complex tooth alignment and correction of dental malocclusions.
The system is supplied as a sterile, single-use device and is intended for use in orthodontic practices. It is regulated under 21 CFR 872.3640 and has received FDA 510(k) clearance (K202790) as substantially equivalent to a predicate device. Multiple screw sizes and configurations are available, as indicated by the registration numbers (e.g., 1032347, 3009732568). Proper handling and insertion require adherence to orthodontic protocols, with storage in a clean, dry environment to maintain sterility.
Frequently asked questions
What is the Syntec Orthodontic Mini Screw Extended System used for?
This system is designed for skeletal anchorage in orthodontic treatment. It provides stable fixation points within bone to support orthodontic appliances, enabling precise tooth movement and correction of dental malocclusions without relying on patient cooperation. The screws act as reliable anchors for complex alignment cases where traditional methods may fall short.
How is the Syntec Orthodontic Mini Screw Extended System supplied and what does this mean for use?
The system is supplied as a sterile, single-use device. This means each unit is pre-sterilized and intended for one-time use only, reducing the risk of cross-contamination and ensuring patient safety. Clinicians must adhere to orthodontic protocols during insertion and handle the device carefully to maintain sterility throughout the procedure.
Are there different sizes or configurations available for this system?
Yes, the Syntec Orthodontic Mini Screw Extended System comes in multiple screw sizes and configurations, each identified by unique registration numbers (e.g., 1032347, 3009732568). These variations allow clinicians to select the appropriate screw based on patient anatomy and treatment requirements, ensuring optimal stability and fit for skeletal anchorage.
How should the Syntec Orthodontic Mini Screw Extended System be stored to maintain its integrity?
The system must be stored in a clean, dry environment to preserve sterility and functionality. Proper storage conditions prevent moisture, dust, or damage to the packaging, which could compromise the device’s readiness for use. Always follow manufacturer guidelines for packaging and storage to ensure the screws remain viable until insertion.
What regulatory pathway does the Syntec Orthodontic Mini Screw Extended System follow?
The system has received FDA 510(k) clearance (K202790) as substantially equivalent to a predicate device, confirming its compliance with U.S. regulatory standards for orthodontic implants. It is classified under FDA Product Code OAT and regulated under 21 CFR 872.3640. This clearance ensures the device meets established safety and effectiveness criteria for skeletal anchorage in orthodontic applications.
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: K202790 - Syntec Orthodontic Mini Screw Extended System - FDA 510 (k), Syntec Orthodontic Mini Screw Extended System (K202790) — FDA 510(k ..., Mini Screw & Plate System - SYNTEC SCIENTIFIC CORPORATION, PDF Syntec Scientific Corporation c/o Nicole Tseng Senior Regulatory ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202790 | Class II | Active |
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Manufacturer
- Manufacturer
- Syntec Scientific Corporation
Sources (1)
- FDA 510(k) K202790 24 fields · synced Oct 1, 2026