Cleared Special

K150797 - Digital Dental Intra Oral Sensor, EzSensor Smart

K150797 is an FDA 510(k) clearance for Digital Dental Intra Oral Sensor, manufactured by Rayence Co., Ltd.. The device is a Class 2 Radiology device with product code MUH cleared through the Special 510(k) pathway after a 36-day FDA review.

K150797 · Rayence Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
36d
Days
Class 2
Risk

K150797 is an FDA 510(k) clearance for the Digital Dental Intra Oral Sensor, EzSensor Smart. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on May 1, 2015 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150797

510(k) Number K150797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2015
Decision Date May 01, 2015
Days to Decision 36 days
Submission Type Special
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
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

MUH Device Classification - Class 2, Special Controls

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

Mtechgroup
Dave Kim

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 206
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K150797.
SOPIX
K142995 · Sopro - Acteon Group · Aug 2015
PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner
K151053 · Sopro - Acteon Group · Jul 2015
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
K151707 · Rayence Co., Ltd. · Jul 2015
RAYSCAN A-EXPERT
K142058 · Ray Co., Ltd. · Apr 2015
NICAL SMART MICRO CR system for intraoral dental images
K143703 · Nical Spa · Mar 2015
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio
K143753 · Rayence Co., Ltd. · Mar 2015
K150797 · Digital Dental Intra Oral Sensor, EzSensor Smart
Download PDF FDA Summary Rayence Co., Ltd.