Cleared Special

K140056 - DIGITAL DENTAL INTRA ORAL SENSOR

Also marketed or referenced as:
HDI 1000, HDI 1000A

K140056 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 MQB cleared through the Special 510(k) pathway after a 123-day FDA review.

K140056 · Rayence Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
123d
Days
Class 2
Risk

K140056 is an FDA 510(k) clearance for the DIGITAL DENTAL INTRA ORAL SENSOR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Rayence Co., Ltd. (Houston, US). The FDA issued a Cleared decision on May 13, 2014 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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. Standard predicate reliance. 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 - K140056

510(k) Number K140056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2014
Decision Date May 13, 2014
Days to Decision 123 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
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K140056.
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K140771 · Philips Medical Systems Dmc GmbH · Apr 2014
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K133524 · Portavision Medical, LLC · Apr 2014
K140056 · DIGITAL DENTAL INTRA ORAL SENSOR
Download PDF FDA Summary Rayence Co., Ltd.