Skip to content

Apolonia Laser Implant System

by Csm Implant Co., Ltd. 510(k)

Active United States

510(k) K102635

Overview

The Apolonia Laser Implant System is an endosseous, root-form dental implant. It is classified under product code DZE and has been determined to be substantially equivalent to a predicate device.

The system received traditional 510(k) clearance from the FDA under K102635, with a decision date of March 22, 2011. It is manufactured by CSM Implant Co., Ltd. and is intended for use in dental applications.

AI-generated from registry data, 27 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 NumberK102635 Date22 Mar 2011ClearedStatusActive

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 Csm Implant Co., Ltd.

Questions

  • What is the Apolonia Laser Implant System used for?

    The Apolonia Laser Implant System is an endosseous, root-form dental implant intended for use in dental applications, specifically to support prosthetic teeth in the jawbone.

  • How is the Apolonia Laser Implant System supplied or packaged?

    The device data does not specify packaging or supply details for the Apolonia Laser Implant System; only its classification, manufacturer, and FDA 510(k) clearance information are provided.

  • Is the Apolonia Laser Implant System sterile or single-use?

    The device data does not indicate whether the Apolonia Laser Implant System is sterile, single-use, or reusable; such details are not included in the provided specifications or authorization information.

  • What sizes or models are available for the Apolonia Laser Implant System?

    The device data does not list specific sizes, models, or reference numbers for the Apolonia Laser Implant System beyond its name and product code DZE; no dimensional or variant details are provided.

  • What regulatory pathway was used for the Apolonia Laser Implant System?

    The Apolonia Laser Implant System received traditional 510(k) clearance from the FDA under K102635, with a decision date of March 22, 2011, based on a determination of substantial equivalence to a predicate device.