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ImplantMax Software

by Saturn Imaging, Inc.

510(k) K151152

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 NumberK151152 Date12 Jan 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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

ImplantMax Software is a stand-alone Windows-based software application designed to support diagnosis and treatment planning for dental implantation. It is intended for use by qualified dental practitioners, including dentists and lab technicians.

This device is cleared under FDA 510(k) number K151152. It is categorized under product code LLZ and is associated with the radiology advisory committee.

Questions

AI-generated answers, 23 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 intended use of ImplantMax Software?

    ImplantMax Software is a stand-alone application designed to assist qualified dental practitioners, such as dentists and lab technicians, in the diagnosis and treatment planning process for dental implantation procedures.

  • What are the system requirements for this software?

    ImplantMax Software is designed as a Windows-based application, meaning it is compatible with the Windows operating system environment for clinical use.

  • What is the regulatory status of this device?

    ImplantMax Software is cleared under FDA 510(k) number K151152. It is categorized under product code LLZ and is associated with the radiology advisory committee.