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FDA 510(k)

BICONITE SURFACE TREATMENT

K-Number: K031568 · 2004-11-23

ApplicantBicon, Inc.
Decision Date2004-11-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BICONITE SURFACE TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Bicon, Inc.. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K031568. 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 BICONITE SURFACE TREATMENT?

BICONITE SURFACE TREATMENT is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Bicon, Inc.. The 510(k) number is K031568.

When did BICONITE SURFACE TREATMENT receive FDA 510(k) clearance?

BICONITE SURFACE TREATMENT received FDA 510(k) clearance on 2004-11-23, under 510(k) number K031568.

Who is the listed applicant for BICONITE SURFACE TREATMENT?

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 BICONITE SURFACE TREATMENT?

The FDA product code for BICONITE SURFACE TREATMENT 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 SYSTEMK042637THE 5.0 X 6.0MM DENTAL IMPLANTK023705BICON TRANSITIONAL IMPLANT (BTI) SYSTEM

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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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