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FDA 510(k)

BV Dental Implant System

K-Number: K192274 · 2020-06-18

Decision Date2020-06-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BV Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Bio Concept Co., Ltd.. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K192274. 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 BV Dental Implant System?

BV Dental Implant System is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Bio Concept Co., Ltd.. The 510(k) number is K192274.

When did BV Dental Implant System receive FDA 510(k) clearance?

BV Dental Implant System received FDA 510(k) clearance on 2020-06-18, under 510(k) number K192274.

Who is the listed applicant for BV Dental Implant System?

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

What is the FDA product code for BV Dental Implant System?

The FDA product code for BV Dental Implant System is DZE.

Other records listing Bio Concept 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.

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.

Official Source

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