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FDA 510(k)

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

K-Number: K041655 · 2004-09-08

ApplicantCowellmedi Co., Ltd.
Decision Date2004-09-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K041655. 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 BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)?

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K041655.

When did BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) receive FDA 510(k) clearance?

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) received FDA 510(k) clearance on 2004-09-08, under 510(k) number K041655.

Who is the listed applicant for BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)?

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

What is the FDA product code for BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)?

The FDA product code for BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) is DZE.

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Other records listing Cowellmedi Co., Ltd. as applicant

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Related Devices (Code: DZE)

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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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