Identifiers
- 510(k) Number
- K191458 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)
Legacy SMARTBase Abutments are dental implant components designed to support prosthetic restorations in partially edentulous patients. These engaging abutments are intended for use in the mandible or maxilla to provide support for single unit restorations.
The Legacy SMARTBase Abutment system is supplied as a complete range of TiBase abutments with dual-hue anodization. The device has FDA 510(k) clearance K191458 and is manufactured by Implant Direct Sybron Manufacturing LLC. The abutments are designed to offer restorative flexibility for both clinicians and laboratories.
Frequently asked questions
What are Legacy SMARTBase Abutments used for?
Legacy SMARTBase Abutments are dental implant components designed to support prosthetic restorations in partially edentulous patients, providing support for single unit restorations in the mandible or maxilla.
What is included in the Legacy SMARTBase Abutment system?
The Legacy SMARTBase Abutment system is supplied as a complete range of TiBase abutments with dual-hue anodization, offering restorative flexibility for both clinicians and laboratories.
What is the regulatory status of Legacy SMARTBase Abutments?
Legacy SMARTBase Abutments have FDA 510(k) clearance K191458 and are manufactured by Implant Direct Sybron Manufacturing LLC, with a decision date of 2019-10-10.
Are Legacy SMARTBase Abutments available in different sizes or models?
The Legacy SMARTBase Abutment system is supplied as a complete range of TiBase abutments with dual-hue anodization, providing various options for different clinical needs.
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: SMARTbase™ TiBase Abutments | Implant Direct, PDF Implant Direct Sybron Manufacturing LLC ℅ Yarmela Pavlovic Partner ..., Legacy SMARTBase Abutments (K191458) - FDA 510 (k), Legacy SmartBase Abutments Recalled for Lack of FDA Clearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191458 | Class II | Active |
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Manufacturer
- Manufacturer
- Implant Direct Sybron Manufacturing Llc
- FDA Applicant
- Implant Direct Sybron Manufacturing, LLC
Sources (1)
- FDA 510(k) K191458 24 fields · synced Sep 24, 2026