High Retention Attachment System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213391 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 designed for overdentures, providing secure retention for removable prosthetics in fully or partially edentulous patients. Classified under dental implant attachments, it ensures stable fixation to implant abutments, improving functional stability and patient comfort during use.
This system is supplied as a reusable component intended for clinical use in dental settings. It is intended for single-patient use per manufacturer specifications and requires proper sterilization between applications. The device is regulated under FDA 510(k) clearance (K213391) and adheres to dental implant attachment standards, ensuring compliance with U.S. regulatory requirements for dental restorative solutions.
Frequently asked questions
What is the High Retention Attachment System used for in dental procedures?
The High Retention Attachment System is designed specifically for securing overdentures in patients who are fully or partially edentulous. It provides stable fixation to dental implant abutments, enhancing the functional stability and comfort of removable prosthetics during daily use.
Is the High Retention Attachment System intended for single-use or reusable applications?
The system is supplied as a reusable component but must be used for only one patient at a time per manufacturer guidelines. It requires proper sterilization between uses to ensure safety and compliance with clinical standards.
How is the High Retention Attachment System regulated in the U.S.?
The device is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K213391. It was determined to be substantially equivalent to a predicate device and falls under the dental implant attachment category, adhering to U.S. regulatory requirements for dental restorative solutions.
What type of sterilization is required for the High Retention Attachment System between patient uses?
Since the system is reusable but intended for single-patient use, it must undergo proper sterilization between applications to maintain safety and hygiene. The manufacturer specifies adherence to clinical sterilization protocols to ensure the device remains suitable for reuse.
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), PDF Zest Anchors, LLC c/o Melissa Burbage RA Sr Specialist PaxMed ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213391 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (1)
- FDA 510(k) K213391 24 fields · synced Sep 18, 2026