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A Plus Internal Fixture System

by T-Plus Implant Tech. Co., Ltd. 510(k)

Active United States

510(k) K152786

Overview

A Plus Internal Fixture System consists of Grade 4 titanium root-form dental implants, abutments, and accessories. It is used by dentists in clinical settings to replace missing teeth.

Implants are surgically placed into the upper or lower jaw and support screw- or cement-retained prosthetic restorations. The device restores patient chewing function. It is supplied as a system and is subject to FDA 510(k) clearance under K152786.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152786 Date7 Jun 2016ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from T-Plus Implant Tech. Co., Ltd.

Questions

  • What is the A Plus Internal Fixture System used for?

    The A Plus Internal Fixture System is used by dentists in clinical settings to replace missing teeth by surgically placing Grade 4 titanium root-form implants into the upper or lower jaw to support screw- or cement-retained prosthetic restorations and restore chewing function.

  • What materials and components are included in the A Plus Internal Fixture System?

    The system consists of Grade 4 titanium root-form dental implants, abutments, and accessories, all supplied as a complete system for clinical use in tooth replacement procedures.

  • How is the A Plus Internal Fixture System supplied and what is its regulatory status?

    The device is supplied as a system and received FDA 510(k) clearance under K152786, with a decision date of June 7, 2016, based on a traditional submission found substantially equivalent to a predicate device.