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Trefoil System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152836

by Nobel Biocare AB

Identifiers

510(k) Number
K152836 FDA 510(k)
FDA Product Code
DZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Trefoil System is a dental implant device designed for full-arch tooth replacement in the lower jaw, classified under dental implant nomenclature. It provides a fixed prosthetic solution supported by strategically placed implants to restore function and aesthetics in edentulous patients.

This system is supplied as a complete kit for surgical and prosthetic placement, intended for single-use per patient. It is regulated under the FDA 510(k) clearance (K152836) and the Medical Device Directive (MDD), with no third-party involvement. Sterility and sizing are manufacturer-specified, adhering to dental implant standards for lower-arch applications.

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: Trefoil - Nobel Biocare dental implants - Nobel Biocare, K172352 FDA 510 (k) - TREFOIL System | Nobel Biocare AB, Trefoil™ Implant System - - Nobel Biocare dental implant microsite example

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nobel Biocare AB

Sources (2)

  • FDA 510(k) K152836 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026