Digital Dental Image Scanner

No FDA recalls on record, checked 22 Oct 2026.

Full name

Digital image scanner of dental

510(k) Number

K231660 ↗

FDA Product Code

MUH

FDA applicant

Jiangsu Dynamic Medical Technology Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Medical Suction Unit

  Class I

  CE/MDR

• Air compressor

  Class I

  CE/MDR

• Power system

  Class I

  CE/MDR

• Air compressor

  Class I

  CE/MDR

• Air compressor

  Class I

  CE/MDR

• Medical Suction Unit

  Class I

  CE/MDR

See all devices from Jiangsu Dynamic Medical Technology Co., Ltd →

• Is this dental image scanner designed for single-use or can it be reused in a clinical setting?

  This device is explicitly described as a reusable medical device. Since it is classified as an extraoral X-ray system with a digital receptor, it is intended for repeated use in dental clinics and oral healthcare settings, though standard decontamination and maintenance procedures must be followed to ensure safety and functionality.

• What types of dental images can this scanner capture, and how does it differ from traditional film-based methods?

  This scanner captures high-resolution radiographic images of dental structures, including extraoral views, replacing traditional film-based methods. Unlike film, it uses digital imaging technology, allowing for immediate viewing, storage, and sharing of images—eliminating the need for chemical processing and reducing patient exposure to radiation during retakes.

• Are there multiple models available, and if so, how can I identify the correct registration number for my needs?

  Yes, multiple model variants exist, each with its own registration number (e.g., 3000190675, 3038718579, etc.). These numbers are tied to specific submissions under the FDA 510(k) clearance (K231660) and regulatory product code MUH. To identify the correct model, consult the manufacturer’s documentation or contact Jiangsu Dynamic Medical Technology Co., Ltd. directly, as the provided data does not specify size or variant distinctions.

• Does this device require sterilization before use, and if not, what cleaning procedures should be followed?

  The provided data does not explicitly state sterilization requirements, but since it is reusable, standard decontamination protocols (e.g., cleaning with approved disinfectants) must be followed to prevent cross-contamination. Always refer to the manufacturer’s instructions for use (IFU) for specific cleaning guidelines, as improper handling could affect performance or regulatory compliance.

• How is this device regulated, and what does the FDA’s classification mean for dental professionals?

  This device falls under FDA Class II regulatory classification and was cleared via a Traditional 510(k) pathway (K231660) with a Substantially Equivalent (SESE) determination. The Dental advisory committee (DE) reviewed it, and it adheres to product code MUH and regulation 872.1800. For dental professionals, this means it meets FDA standards for safety and effectiveness as an extraoral X-ray system, though compliance with local facility protocols and radiation safety guidelines remains mandatory.