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Etex Dental Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K913417

by Etex Co.

Identifiers

510(k) Number
K913417 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)

Etex Dental Implant System by Etex Co. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Etex Co.

Sources (1)

  • FDA 510(k) K913417 24 fields · synced Jun 19, 2026