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Orthopantomograph OP200, OP200D, Orthoceph OC200, OC200D

by Instrumentarium Corp. Imaging Division

510(k) K043612

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 NumberK043612 Date9 Feb 2005ClearedStatusActive

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  • Withdrawn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)

Full name
Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D
510(k) Number
FDA Product Code
EHD
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 OP200, OP200D, Orthoceph OC200, and OC200D are extraoral X-ray units designed for panoramic dental imaging. These devices capture comprehensive views of the maxillofacial region, including the teeth, jaws, and surrounding structures, in a single exposure. The OP200 and OC200 models operate using film-based imaging, while the OP200D and OC200D incorporate digital technology to produce radiographic images. Their primary function is to aid in the diagnosis and treatment planning for dental, orthodontic, and maxillofacial conditions by providing detailed panoramic radiographs.

These devices are intended for use in dental clinics and oral healthcare settings. The OP200 and OC200 models utilize film cassettes, whereas the OP200D and OC200D feature digital sensors for image capture. All models include motorized patient positioning, a panoramic mirror, and a rigid forehead support to ensure consistent and accurate imaging. They are classified as Class II medical devices under FDA regulations and have received 510(k) clearance for dental use. The devices are not intended for MRI environments and must be stored in a controlled environment to maintain proper functionality and sterility where applicable.

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