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Implacil Implant System

by Implacil DE Bortoli Material Odontologico Ltda 2 variants

510(k) K183024

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183024 Date13 Feb 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic dental restorations, such as crowns, bridges, or dentures. The Implacil Implant System is a Class II dental implant system identified by product code DZE.

The device is supplied non-sterile and requires sterilization prior to use. It is intended for single-use implantation and is regulated under 21 CFR 872.3640. The system received FDA 510(k) clearance (K183024) on February 13, 2020, and is manufactured by Implacil DE Bortoli Material Odontologico Ltda in Sao Paulo, Brazil.

Other devices from Implacil DE Bortoli Material Odontologico Ltda

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Implacil Implant System used for?

    The Implacil Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic dental restorations such as crowns, bridges, or dentures, as it functions as an endosseous dental implant.

  • How is the Implacil Implant System supplied and prepared for use?

    The device is supplied non-sterile and must be sterilized by the user prior to surgical implantation, as it is not provided in a sterile condition and requires processing before use.

  • Is the Implacil Implant System designed for single use or reuse?

    The Implacil Implant System is intended for single-use implantation only, meaning each implant should be used for one patient and one procedure, then discarded to ensure safety and performance.