Orthophos Plus and Orthophos Plus/CD

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K972249 ↗

FDA Product Code

EHD

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Siemens Sirona(R) Dental Chair

  Class I

  FDA 510(k) K863484 Active Cleared 19 Sep 1986

• Heliodent Ds

  Class II

  FDA 510(k) K960819 Active Cleared 29 Mar 1996

• Resubmitted Water Purifier for Use W/Dental Treat

  Class I

  FDA 510(k) K901672 Active Cleared 6 Jul 1990

• Sirolux Fantastic

  Class I

  FDA 510(k) K935390 Active Cleared 10 Dec 1993

• Heliodent Md

  Class II

  FDA 510(k) K950030 Active Cleared 3 Feb 1995

• Cerec 2

  Class II

  FDA 510(k) K950299 Active Cleared 23 May 1995

See all devices from Pelton & Crane Co. →

• What is the Orthophos Plus/CD used for?

  The Orthophos Plus/CD is designed for producing radiographic images of teeth, jaws, and oral structures. This enables clinicians to diagnose dental and maxillofacial conditions accurately, supporting treatment planning and monitoring of oral health issues.

• Is the Orthophos Plus/CD a single-use or reusable device?

  The Orthophos Plus/CD is a reusable device. It is intended for repeated use in dental offices and clinics, provided it undergoes proper maintenance and storage to ensure operational integrity and compliance with radiation safety standards.

• What distinguishes the Orthophos Plus/CD from the Orthophos Plus?

  The Orthophos Plus/CD includes a CD output feature, enabling digital imaging capabilities. The Orthophos Plus, while also an extraoral dental X-ray unit with an integrated timer, does not offer this digital output functionality.

• How should the Orthophos Plus/CD be stored?

  The Orthophos Plus/CD should be stored in a clean, dry environment, protected from physical damage and excessive moisture. Proper storage ensures the device remains operational and maintains compliance with radiation safety regulations. Follow manufacturer guidelines for specific storage instructions.

• What regulatory pathway was used for FDA clearance of the Orthophos Plus/CD?

  The Orthophos Plus/CD was cleared under the FDA’s Traditional 510(k) pathway, with clearance number K972249. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness.