Cleared Traditional

K231660 - Digital image scanner of dental (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231660 · Jiangsu Dynamic Medical Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
196d
Days
Class 2
Risk

K231660 is an FDA 510(k) clearance for the Digital image scanner of dental. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Jiangsu Dynamic Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 20, 2023 after a review of 196 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Jiangsu Dynamic Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K231660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2023
Decision Date December 20, 2023
Days to Decision 196 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 107d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Shanghai CV Technology Co., Ltd.
Doris Dong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUH System, X-ray, Extraoral Source, Digital

All 205
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K231660.
SOTA Cloud Smart Sensor (1.5)
K251793 · Sota Cloud Corp. · Mar 2026
EzSensor HD, EzSensor UHD
K252570 · Qpix Solutions, Inc. · Nov 2025
Cocoon Solo (DX-7020s)
K250687 · Dexcowin Global, Inc. · Oct 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · Dentimax, Inc. · Sep 2025
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040 · VATECH Co., Ltd. · Oct 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · Qpix Solutions, Inc. · Oct 2024