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Minxray BPD60

by Minxray, Inc.

510(k) K091255

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091255 Date12 May 2010ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Minxray, Model: BPD60
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, 1 Oct 2026

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

The Minxray BPD60 is an Extraoral X-Ray Unit with Timer, designed for dental radiography. This device captures high-quality radiographic images of teeth and surrounding structures using extraoral techniques, providing detailed visualisation for diagnostic purposes in dental practice. Its classification as a Class II medical device reflects its role in capturing precise images essential for assessing dental conditions.

The BPD60 is supplied as a reusable dental X-ray unit, intended for use in clinical settings such as dental offices. It operates under FDA 510(k) clearance (K091255) and adheres to regulatory standards outlined in 21 CFR 872.1800. The device is not indicated for MRI environments and requires proper calibration and maintenance per manufacturer guidelines. Storage and handling follow standard protocols for radiographic equipment to ensure optimal performance and safety.

Similar devices

Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).

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