Cleared Traditional

K002062 - SAMSUNG 10DR IMPLANT SYSTEM

K002062 is an FDA 510(k) clearance for SAMSUNG 10DR IMPLANT SYSTEM, manufactured by Samsung Sds Co., Ltd.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K002062 · Samsung Sds Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
126d
Days
Class 2
Risk

K002062 is an FDA 510(k) clearance for the SAMSUNG 10DR IMPLANT SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Samsung Sds Co., Ltd. (Aubrey, US). The FDA issued a Cleared decision on November 9, 2000 after a review of 126 days - within the typical 510(k) review window.

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 - K002062

510(k) Number K002062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2000
Decision Date November 09, 2000
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
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 188
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K002062.
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
K013176 · Afp Imaging Corp. · Oct 2001
IMAGE-X SYSTEM
K012355 · Tg Group, Inc. · Aug 2001
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · Planmeca Oy · Jun 2001
STRATO X
K002432 · Villa Sistemi Medicali S.P.A. · Sep 2000
FOCUS
K001729 · Instrumentarium Corp. · Jul 2000
MULTI-PULSE 2000
K001248 · Imaging Sciences Intl., Inc. · May 2000
K002062 · SAMSUNG 10DR IMPLANT SYSTEM
Download PDF FDA Summary Samsung Sds Co., Ltd.