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FDA 510(k)

OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE

K-Number: K063286 · 2007-04-24

ApplicantImplant Innovations, Inc.
Decision Date2007-04-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE is the device name listed in this FDA 510(k) record. The listed applicant is Implant Innovations, Inc.. It received FDA 510(k) clearance on 2007-04-24 under 510(k) number K063286. 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 OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE?

OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE is a medical device that received FDA 510(k) clearance on 2007-04-24. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K063286.

When did OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE receive FDA 510(k) clearance?

OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE received FDA 510(k) clearance on 2007-04-24, under 510(k) number K063286.

Who is the listed applicant for OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE?

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

What is the FDA product code for OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE?

The FDA product code for OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE is DZE.

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Other records listing Implant Innovations, 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.

K062636OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTSK0633413I OSSEOTITE CERTAIN DENTAL IMPLANTSK063403CONICAL ANGLED ABUTMENTK061629CERTAIN PREVAIL DENTAL IMPLANTK062432NANOTITE DENTAL IMPLANTSK061969PREFORMANCE POSTS AND TEMPORARY CYLINDERS

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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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