Identifiers
- 510(k) Number
- K260555 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 Locator Angled Abutment is a dental implant abutment designed for the attachment of full or partial, fixed, and removable restorations. It is intended to restore masticatory function by securing prosthetic restorations to endosseous implants, providing a stable connection for overdentures or hybrid prostheses.
This device is supplied sterile and intended for single-use, though it may be reusable under proper sterilization protocols as determined by the manufacturer. It is classified under product code NHA and has received FDA 510(k) clearance as a Special type under the Dental advisory committee. The angled design accommodates varying anatomical constraints, and it is compatible with standard implant systems for use in oral environments.
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: Locator Angled Abutments | Zest Dental Solutions, PDF LOCATOR® ANGLED ABUTMENT - Amazon Web Services, LOCATOR® Angled Abutment by Zest Anchors, LLC | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260555 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (1)
- FDA 510(k) K260555 24 fields · synced Sep 18, 2026