Hex-Lock Prepared Abutment (Straight & Angled)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052600 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hex-Lock Prepared Abutment (Straight & Angled) is a dental implant abutment designed for use as a terminal or intermediate component in cemented prostheses. It features a hex connection for secure attachment to dental implants and is available in straight and angled configurations, with the angled version providing a 17° offset for restoring misaligned implant sites. This device facilitates the placement of single or multiple-unit restorations by ensuring proper alignment and stability of the prosthetic crown or bridge. Its design adheres to dental implant standards for abutment functionality and integration with prosthetic systems.
These abutments are supplied sterile and intended for single-use in clinical settings. They are compatible with MRI environments and must be handled with sterile techniques to prevent contamination. The device is regulated under FDA 510(k) clearance (K052600) as a dental implant component, with no third-party certification noted. Storage should follow manufacturer guidelines to maintain sterility and structural integrity, and proper disposal procedures must be observed after use to comply with medical waste regulations.
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: Zimmer Dental Hex-lock Prepared Abutment (Straight & Angled) (K052600 ..., TSX® and TSV® Other Prosthetic Components | ZimVie Americas, Zimmer® Abutments, Analogs, and Implant Accessories Online
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052600 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Dental Inc.
- FDA Applicant
- Zimmer Dental, Inc.
Sources (1)
- FDA 510(k) K052600 24 fields · synced Oct 6, 2026