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FDA 510(k)

SAMSUNG 10DR IMPLANT SYSTEM

K-Number: K002062 · 2000-11-09

ApplicantSamsung Sds Co., Ltd.
Decision Date2000-11-09
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAMSUNG 10DR IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Sds Co., Ltd.. It received FDA 510(k) clearance on 2000-11-09 under 510(k) number K002062. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMSUNG 10DR IMPLANT SYSTEM?

SAMSUNG 10DR IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2000-11-09. The listed applicant is Samsung Sds Co., Ltd.. The 510(k) number is K002062.

When did SAMSUNG 10DR IMPLANT SYSTEM receive FDA 510(k) clearance?

SAMSUNG 10DR IMPLANT SYSTEM received FDA 510(k) clearance on 2000-11-09, under 510(k) number K002062.

Who is the listed applicant for SAMSUNG 10DR IMPLANT SYSTEM?

The FDA 510(k) record lists Samsung Sds Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAMSUNG 10DR IMPLANT SYSTEM?

The FDA product code for SAMSUNG 10DR IMPLANT SYSTEM is EHD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Samsung Sds Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992426RAYPAX WEB CLINICAL SYSTEMK992306SAMSUNG RAYPAX DISPLAY WORKSTATIONK992131SAMSUNG RAYPAX LONG TERM ARCHIVEK992112SAMSUNG RAYPAX FILM DIGITIZERK991537SAMSUNG RAYPAX SYSTEM

Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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