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FDA 510(k)

OSSEOFUSE DENTAL IMPLANT SYSTEM

K-Number: K110577 · 2011-07-14

ApplicantDynamic Innovations, Inc.
Decision Date2011-07-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEOFUSE DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dynamic Innovations, Inc.. It received FDA 510(k) clearance on 2011-07-14 under 510(k) number K110577. 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 OSSEOFUSE DENTAL IMPLANT SYSTEM?

OSSEOFUSE DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-14. The listed applicant is Dynamic Innovations, Inc.. The 510(k) number is K110577.

When did OSSEOFUSE DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

OSSEOFUSE DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2011-07-14, under 510(k) number K110577.

Who is the listed applicant for OSSEOFUSE DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for OSSEOFUSE DENTAL IMPLANT SYSTEM?

The FDA product code for OSSEOFUSE DENTAL IMPLANT SYSTEM 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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