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FDA 510(k)

BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION

K-Number: K092035 · 2009-10-15

ApplicantBicon, LLC
Decision Date2009-10-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION is the device name listed in this FDA 510(k) record. The listed applicant is Bicon, LLC. It received FDA 510(k) clearance on 2009-10-15 under 510(k) number K092035. 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 BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION?

BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION is a medical device that received FDA 510(k) clearance on 2009-10-15. The listed applicant is Bicon, LLC. The 510(k) number is K092035.

When did BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION receive FDA 510(k) clearance?

BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION received FDA 510(k) clearance on 2009-10-15, under 510(k) number K092035.

Who is the listed applicant for BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION?

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

What is the FDA product code for BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION?

The FDA product code for BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION is DZE.

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Other records listing Bicon, LLC 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.

K101849BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANTK0733685.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT

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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