Cleared Traditional

K181297 - DENTIOIII series (DENTIOIII

K181297 is an FDA 510(k) clearance for DENTIOIII series (DENTIOIII, manufactured by Hdx Will Corp.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K181297 · Hdx Will Corp. · Radiology device
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Nov 2018
Decision
189d
Days
Class 2
Risk

K181297 is an FDA 510(k) clearance for the DENTIOIII series (DENTIOIII, DENTIOIII-S). Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Hdx Will Corp. (Cheongju-Si, KR). The FDA issued a Cleared decision on November 21, 2018 after a review of 189 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 Hdx Will Corp. devices

FDA 510(k) Submission Details - K181297

510(k) Number K181297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2018
Decision Date November 21, 2018
Days to Decision 189 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
82d slower than avg
Panel avg: 107d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 89
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K181297.
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