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Phot-X II, Model 303

by Takara Belmont USA, Inc.

510(k) K042260

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 NumberK042260 Date7 Sep 2004ClearedStatusActive

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  • Withdrawn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
EHD
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 PHOT-X II, MODEL 303 is a dental extraoral X-ray unit with timer, classified as a Class II medical device under FDA regulation number 872.1800 and product code EHD. It is substantially equivalent to a legally marketed device and was cleared via the traditional 510(k) pathway (K042260) on September 7, 2004.

This device is intended for use in dental settings in the USA and Canada. It is supplied as a non-sterile, reusable system requiring operator training and adherence to safety instructions. No user-serviceable components are present, and it must be operated according to the provided manual to ensure safe exposure factors.

Other devices from Takara Belmont USA, Inc.

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 PHOT-X II MODEL 303 used for?

    The PHOT-X II MODEL 303 is a dental extraoral X-ray unit with timer intended for use in dental settings in the USA and Canada to capture extraoral radiographic images, as specified in its FDA 510(k) clearance.

  • Is the PHOT-X II MODEL 303 sterile or non-sterile, and is it single-use or reusable?

    The PHOT-X II MODEL 303 is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is designed for repeated use after proper cleaning and maintenance in accordance with the operator manual.

  • What training or safety requirements are associated with operating the PHOT-X II MODEL 303?

    Operator training is required to safely operate the PHOT-X II MODEL 303, and users must adhere to the safety instructions provided in the manual to ensure correct exposure factors and safe operation, as no user-serviceable components are present.