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FDA 510(k)

THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM

K-Number: K972417 · 1997-09-17

ApplicantBicon, Inc.
Decision Date1997-09-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bicon, Inc.. It received FDA 510(k) clearance on 1997-09-17 under 510(k) number K972417. 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 THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM?

THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-17. The listed applicant is Bicon, Inc.. The 510(k) number is K972417.

When did THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1997-09-17, under 510(k) number K972417.

Who is the listed applicant for THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM?

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 THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM?

The FDA product code for THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM 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

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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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