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FDA 510(k)

DENOVISMED DENTAL IMPLANT SYSTEMS

K-Number: K083543 · 2009-03-06

ApplicantDenovis Medical, LLC
Decision Date2009-03-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENOVISMED DENTAL IMPLANT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Denovis Medical, LLC. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K083543. 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 DENOVISMED DENTAL IMPLANT SYSTEMS?

DENOVISMED DENTAL IMPLANT SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is Denovis Medical, LLC. The 510(k) number is K083543.

When did DENOVISMED DENTAL IMPLANT SYSTEMS receive FDA 510(k) clearance?

DENOVISMED DENTAL IMPLANT SYSTEMS received FDA 510(k) clearance on 2009-03-06, under 510(k) number K083543.

Who is the listed applicant for DENOVISMED DENTAL IMPLANT SYSTEMS?

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

What is the FDA product code for DENOVISMED DENTAL IMPLANT SYSTEMS?

The FDA product code for DENOVISMED DENTAL IMPLANT SYSTEMS is DZE.

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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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