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Orthopantomograph OP30

by Instrumentarium Dental, Palodex Group OY

510(k) K092591

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 NumberK092591 Date20 Nov 2009ClearedStatusActive

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  • Withdrawn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
MUH
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Orthopantomograph OP30 is a digital panoramic dental X-ray unit designed to take panoramic images of the teeth and jaws. It is classified as a Class II medical device under the FDA 510(k) clearance pathway, with product code MUH and regulation number 872.1800.

The device is supplied as a reusable system for use in dental and maxillofacial imaging settings. It requires connection to a power source and is operated by trained dental professionals. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.

Other devices from Instrumentarium Dental, Palodex Group OY

  • Sigma M

    Class II

  • Orthopantomograph OP300

    Class II

  • Digora Optime

    Class II

  • Snapshot

    Class II

Questions

AI-generated answers, 26 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 Orthopantomograph OP30 used for?

    The Orthopantomograph OP30 is designed to take panoramic images of the teeth and jaws in dental and maxillofacial imaging settings, enabling clinicians to assess oral structures for diagnostic purposes.

  • How is the Orthopantomograph OP30 supplied and is it reusable?

    The device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and maintenance, and is not provided as a single-use or sterile disposable unit.

  • What are the power and operational requirements for the Orthopantomograph OP30?

    The Orthopantomograph OP30 requires connection to a power source to function and must be operated by trained dental professionals who are qualified to use radiographic equipment safely and effectively.