Cleared Traditional

K213282 - ERI Handheld Dental X-ray System (Model AG100)

K213282 is an FDA 510(k) clearance for ERI Handheld Dental X-ray System (Model..., manufactured by Energy Resources International Co., Ltd. Hsinchu Branch. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K213282 · Energy Resources International Co., Ltd. Hsinchu Branch · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
185d
Days
Class 2
Risk

K213282 is an FDA 510(k) clearance for the ERI Handheld Dental X-ray System (Model AG100). Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Energy Resources International Co., Ltd. Hsinchu Branch (Zhubei City, TW). The FDA issued a Cleared decision on April 4, 2022 after a review of 185 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.

FDA 510(k) Submission Details - K213282

510(k) Number K213282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2021
Decision Date April 04, 2022
Days to Decision 185 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
78d slower than avg
Panel avg: 107d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
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 - EHD Unit, X-ray, Extraoral With Timer

All 176
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K213282.
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K213282 · ERI Handheld Dental X-ray System (Model AG100)
Download PDF FDA Summary Energy Resources Inte…