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FDA 510(k)

DENTIUM CO., LTD. IMPLANTIUM

K-Number: K041368 · 2004-07-29

ApplicantDentium Co., Ltd.
Decision Date2004-07-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTIUM CO., LTD. IMPLANTIUM is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2004-07-29 under 510(k) number K041368. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTIUM CO., LTD. IMPLANTIUM?

DENTIUM CO., LTD. IMPLANTIUM is a medical device that received FDA 510(k) clearance on 2004-07-29. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K041368.

When did DENTIUM CO., LTD. IMPLANTIUM receive FDA 510(k) clearance?

DENTIUM CO., LTD. IMPLANTIUM received FDA 510(k) clearance on 2004-07-29, under 510(k) number K041368.

Who is the listed applicant for DENTIUM CO., LTD. IMPLANTIUM?

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

What is the FDA product code for DENTIUM CO., LTD. IMPLANTIUM?

The FDA product code for DENTIUM CO., LTD. IMPLANTIUM is DZE.

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Other records listing Dentium 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.

K213599SuperLineK193341iCTmotor (WL-1)K192436Healing Abutments and Cover ScrewsK191634Scan Abutments and Comfort CapsK172640Dentium Implantium & SuperLine ProstheticsK171622Dentium Ti-Base

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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