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maxFit II Dental Implant System

by Taiwan Implant Technology Company, Ltd.

510(k) K151588

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 NumberK151588 Date25 Apr 2016ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The maxFit II Dental Implant System is a dental implant system designed to replace missing teeth and restore oral function and aesthetics. It is intended for use by dental professionals in implant dentistry.

The device is supplied as a sterile, single-use implant system. It is available in various sizes and requires proper storage conditions. The system is regulated under FDA 510(k) authorization (K151588) and is manufactured by Taiwan Implant Technology Company, Ltd.

Questions

AI-generated answers, 1 Oct 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 maxFit II Dental Implant System used for?

    It is designed to replace missing teeth and restore oral function and aesthetics for dental professionals.

  • Is the maxFit II Dental Implant System sterile and single-use?

    Yes, the device is supplied as a sterile, single-use implant system.

  • What are the storage requirements for the maxFit II Dental Implant System?

    The system requires proper storage conditions to maintain its sterility and functionality.

  • What is the regulatory status of the maxFit II Dental Implant System?

    The device is regulated under FDA 510(k) authorization (K151588).