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FDA 510(k)

OSSEOTITE II MODEL XIFOSSXXX

K-Number: K100724 · 2011-04-01

ApplicantBiomet 3i, Inc.
Decision Date2011-04-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEOTITE II MODEL XIFOSSXXX is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, Inc.. It received FDA 510(k) clearance on 2011-04-01 under 510(k) number K100724. 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 II MODEL XIFOSSXXX?

OSSEOTITE II MODEL XIFOSSXXX is a medical device that received FDA 510(k) clearance on 2011-04-01. The listed applicant is Biomet 3i, Inc.. The 510(k) number is K100724.

When did OSSEOTITE II MODEL XIFOSSXXX receive FDA 510(k) clearance?

OSSEOTITE II MODEL XIFOSSXXX received FDA 510(k) clearance on 2011-04-01, under 510(k) number K100724.

Who is the listed applicant for OSSEOTITE II MODEL XIFOSSXXX?

The FDA 510(k) record lists Biomet 3i, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSEOTITE II MODEL XIFOSSXXX?

The FDA product code for OSSEOTITE II MODEL XIFOSSXXX is DZE.

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Other records listing Biomet 3i, 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.

K111216OSSEOTITE 2 DENTAL IMPLANTSK110565ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACEK101608BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTSK101607BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTSK102209ENCODE PATIENT SPECIFIC ABUTMENTK101582CAM STRUCTSURE BARS

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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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