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FDA 510(k)

HC-BIOS DENTAL IMPLANT

K-Number: K110425 · 2012-07-27

ApplicantHung Chun Bio-S Co., Ltd.
Decision Date2012-07-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HC-BIOS DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Hung Chun Bio-S Co., Ltd.. It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K110425. 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 HC-BIOS DENTAL IMPLANT?

HC-BIOS DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Hung Chun Bio-S Co., Ltd.. The 510(k) number is K110425.

When did HC-BIOS DENTAL IMPLANT receive FDA 510(k) clearance?

HC-BIOS DENTAL IMPLANT received FDA 510(k) clearance on 2012-07-27, under 510(k) number K110425.

Who is the listed applicant for HC-BIOS DENTAL IMPLANT?

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

What is the FDA product code for HC-BIOS DENTAL IMPLANT?

The FDA product code for HC-BIOS DENTAL IMPLANT is DZE.

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Other records listing Hung Chun Bio-S 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.

K172821Ti-one 101 TS Dental Implant SystemK151362HC Spinal System

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

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

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