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Impla-Med Implant System

by Impla-Med

510(k) K892124

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 NumberK892124 Date20 Oct 1989ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

The Impla-Med Implant System is a dental device designed for use in oral surgery and implantology. It functions as a system for the placement of dental implants.

This device is subject to FDA 510k authorization. It is identified by the K892124 submission number and is categorized under the dental advisory committee.

Other devices from Impla-Med

Questions

AI-generated answers, 21 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 primary function of the Impla-Med Implant System?

    The Impla-Med Implant System is designed specifically for use in oral surgery and implantology. It serves as a comprehensive system intended for the placement of dental implants.

  • What is the regulatory status of this implant system?

    The Impla-Med Implant System is subject to FDA 510k authorization. It was reviewed under submission number K892124 and received a decision of Substantially Equivalent on October 20, 1989.

  • Which advisory committee oversees this device?

    This device is categorized under the Dental advisory committee, which is responsible for evaluating submissions related to dental surgical instruments and implant systems.