Cleared Traditional

SAMSUNG 10DR IMPLANT SYSTEM

K002062 · Samsung Sds Co., Ltd. · Radiology
Nov 2000
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K002062 is an FDA 510(k) clearance for the SAMSUNG 10DR IMPLANT SYSTEM, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Samsung Sds Co., Ltd. (Aubrey, US). The FDA issued a Cleared decision on November 9, 2000, 126 days after receiving the submission on July 6, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K002062 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EHD — Unit, X-ray, Extraoral With Timer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

Similar Devices — EHD Unit, X-ray, Extraoral With Timer

All 187
Dental X-RAY Unit (AJX200)
K252110 · Guangzhou Ajax Medical Equipment Co., Ltd. · Mar 2026
Portable Dental X-ray Device (GT-1)
K254018 · Guilin Refine Medical Instrument Co., Ltd. · Feb 2026
Diagnostic X-Ray Equipment Model POCT22
K252909 · Ningbo Runyes Medical Instrument Co., Ltd. · Feb 2026
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · Guilin Woodpecker Medical Instrument Co., Ltd. · Sep 2025
Rextar Pro
K242185 · Raypia Co., Ltd. · Dec 2024
XERO-alpha
K242591 · DRTECH Corporation · Nov 2024