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Point Implant System

by Pointnix Co., Ltd.

510(k) K222738

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 NumberK222738 Date13 Apr 2023ClearedStatusActive

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  • Withdrawn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 Point Implant System is a dental implant device designed for osseointegrated fixation in the jawbone. It is classified under dental implants and intended for use in reconstructive oral and maxillofacial procedures, providing stable anchorage for prosthetic restorations. The system is engineered to facilitate predictable integration with surrounding bone tissue, supporting long-term dental restoration solutions.

This implant system is supplied sterile and intended for single-use. It is regulated under the FDA’s 510(k) clearance (K222738) with a Traditional review pathway, classified under product code DZE for dental implants. The device is intended for use in clinical settings by trained dental professionals and requires proper handling and storage as per manufacturer guidelines to maintain sterility and functionality.

Other devices from Pointnix Co., 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 Point Implant System used for?

    The Point Implant System is designed for osseointegrated fixation in the jawbone, providing stable anchorage for prosthetic restorations in reconstructive oral and maxillofacial procedures. Its engineering ensures predictable integration with surrounding bone tissue, making it suitable for long-term dental restoration solutions.

  • Is the Point Implant System sterile and single-use?

    Yes, the Point Implant System is supplied sterile and intended for single-use only. This ensures patient safety and maintains the device’s integrity for clinical procedures, as recommended by the manufacturer.

  • How is the Point Implant System regulated?

    The Point Implant System has received FDA 510(k) clearance under the Traditional review pathway, classified under product code DZE for dental implants. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for dental implants.

  • Who should use the Point Implant System?

    The Point Implant System is intended for use in clinical settings by trained dental professionals, such as oral surgeons, periodontists, or prosthodontists. Proper handling and adherence to manufacturer guidelines are essential to maintain sterility and functionality during procedures.

  • What storage requirements does the Point Implant System have?

    The Point Implant System must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping the device in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures until use.