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FDA 510(k)

6.0 X 5.7MM DENTAL IMPLANT

K-Number: K010185 · 2002-12-30

ApplicantBicon, Inc.
Decision Date2002-12-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

6.0 X 5.7MM DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Bicon, Inc.. It received FDA 510(k) clearance on 2002-12-30 under 510(k) number K010185. 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 6.0 X 5.7MM DENTAL IMPLANT?

6.0 X 5.7MM DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2002-12-30. The listed applicant is Bicon, Inc.. The 510(k) number is K010185.

When did 6.0 X 5.7MM DENTAL IMPLANT receive FDA 510(k) clearance?

6.0 X 5.7MM DENTAL IMPLANT received FDA 510(k) clearance on 2002-12-30, under 510(k) number K010185.

Who is the listed applicant for 6.0 X 5.7MM DENTAL IMPLANT?

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

What is the FDA product code for 6.0 X 5.7MM DENTAL IMPLANT?

The FDA product code for 6.0 X 5.7MM DENTAL IMPLANT is DZE.

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Other records listing Bicon, Inc. 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.

K062044THE 5.0 X 6.0MM DENTAL IMPLANTK051091SYNTHOGRAFTK0507124.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANTK050408BICON ORTHODONTIC IMPLANT SYSTEMK031568BICONITE SURFACE TREATMENTK042637THE 5.0 X 6.0MM DENTAL IMPLANT

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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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