Chairside Attachment Processing Material
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140570 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a tissue-colored, dual-cure, self-adhesive composite classified as a dental attachment processing material. It is designed for securing attachments to full or partial overdentures, facilitating chairside or laboratory procedures in implant-supported prosthodontics.
The material is supplied as a reusable processing aid for dental laboratories or direct chairside application by clinicians. It is not sterile and must be handled in accordance with standard dental laboratory or clinical protocols. Authorized for use under FDA 510(k) clearance (K140570), it adheres to dental attachment systems for overdenture retention without requiring additional curing agents.
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: CHAIRSIDE® Attachment Processing Material - Zest Dent, LOCATOR CHAIRSIDE® Attachment Processing Material - Zest Dental, PDF 510(k) Summary Zest Anchors, LLC Chairside® Attachment Processing ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140570 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, LLC
Sources (1)
- FDA 510(k) K140570 24 fields · synced Sep 18, 2026