Xpeed AnyRidge Internal Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123870 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 Xpeed AnyRidge Internal Implant System is a dental implant designed for placement in the maxillary or mandibular molar regions. Classified as a dental implant under the FDA’s Product Code DZE, it provides prosthetic support for dental restorations such as crowns, bridges, and overdentures in partially or fully edentulous patients. Its KnifeThread technology and platform-switching design aim to enhance primary stability and preserve surrounding bone structure. The system features a standard core with variable thread depths to accommodate differing bone densities, ensuring adaptability during surgical placement.
The system is supplied as a sterile, single-use implant intended for surgical placement by dental professionals. Implants are available in specific sizes, including the 7mm variant referenced in documentation, and require precise osteotomy preparation tailored to bone condition. Compliance with FDA 510(k) clearance (K123870) confirms its regulatory standing under the Dental Advisory Committee. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to use.
Frequently asked questions
What is the Xpeed AnyRidge Internal Implant System used for?
The Xpeed AnyRidge Internal Implant System is designed for placement in the maxillary or mandibular molar regions to provide prosthetic support for dental restorations. This includes crowns, bridges, and overdentures in patients who are partially or fully edentulous. Its KnifeThread technology and platform-switching design help improve primary stability during placement and preserve surrounding bone structure, making it suitable for long-term dental reconstruction.
How is the Xpeed AnyRidge Internal Implant System supplied and prepared for use?
The system is supplied as a sterile, single-use implant, ensuring safety and sterility for surgical procedures. Implants are intended exclusively for dental professionals to place after precise osteotomy preparation, tailored to the patient’s bone density. The 7mm variant is one of the available sizes, and proper handling and storage under sterile medical device protocols are required before use to maintain its integrity.
Is the Xpeed AnyRidge Internal Implant System reusable or single-use?
The Xpeed AnyRidge Internal Implant System is explicitly designed for single-use only. This design choice aligns with sterile medical device protocols, reducing the risk of cross-contamination and ensuring patient safety. Reuse is not recommended or supported by the manufacturer.
What regulatory approval does the Xpeed AnyRidge Internal Implant System hold?
The Xpeed AnyRidge Internal Implant System holds FDA 510(k) clearance under the classification of a dental implant (Product Code DZE). The clearance (K123870) was granted by the Dental Advisory Committee, confirming its regulatory compliance for use in prosthetic dental restorations. This approval ensures the device meets established safety and effectiveness standards.
How does the variable thread depth feature benefit patients?
The variable thread depth in the Xpeed AnyRidge system allows for adaptability during surgical placement, accommodating differing bone densities. This feature helps optimize primary stability right after implantation, reducing the risk of early failure and promoting better integration with the surrounding bone. The result is improved long-term success for dental restorations like crowns or bridges.
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: AnyRidge Implant System | KnifeThread Technology | MegaGen, AnyRidge - MEGAGEN IMPLANT, PDF 510(k) Summary - MegaGen, XPEED AnyRidge Internal Implant System (7mm) - MegaGen
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123870 | Class II | Active |
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Manufacturer
- Manufacturer
- Megagen Implant Co., Ltd.
Sources (1)
- FDA 510(k) K123870 24 fields · synced Oct 1, 2026