High Retention Attachment System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220252 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 High Retention Attachment System is a dental implant attachment classified under product code NHA, designed for securing overdentures to dental implants. It provides a stable connection for removable prosthetic restorations in fully or partially edentulous patients, ensuring improved retention and comfort.
This system is supplied as a reusable medical device and is intended for use in dental clinical settings. It has received FDA 510(k) clearance under a Special review process, with a decision code of SESE, and is distributed by Zest Anchors, LLC. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the High Retention Attachment System used for in dental practice?
The High Retention Attachment System is specifically designed to secure overdentures to dental implants in patients who are fully or partially edentulous. It provides a stable connection for removable prosthetic restorations, enhancing retention and patient comfort during wear.
Is the High Retention Attachment System intended for single-use or reusable applications?
The High Retention Attachment System is supplied as a reusable medical device, meaning it is intended to be used multiple times in dental clinical settings after proper cleaning and maintenance.
How is the High Retention Attachment System distributed, and who is the manufacturer?
The High Retention Attachment System is manufactured by Zest Anchors, LLC, located in Carlsbad, California, and distributed by the same company. It is classified under product code NHA for dental implant attachments.
What regulatory pathway was followed for FDA clearance of this device?
The High Retention Attachment System received FDA 510(k) clearance through a Special review process, with a decision code of SESE (Substantially Equivalent with Special Emphasis). The submission was filed under the Dental (DE) advisory committee category.
Are there any specific sterility or MRI safety details provided for this device?
The available data for the High Retention Attachment System does not include any explicit information regarding sterility requirements or MRI safety. Clinicians should follow standard dental practice protocols for cleaning and handling reusable devices.
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: K213391 - High Retention Attachment System - Dental, Products > Zest Anchors | Zest Dental Solutions, K220252 - High Retention Attachment System | FDA 510(k), Dental Implant Manufacturer of Overdenture Attachment Systems | Zest ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220252 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (1)
- FDA 510(k) K220252 24 fields · synced Sep 18, 2026