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FDA 510(k)

3I PATIENT-SPECIFIC OVERDENTURE BAR

K-Number: K034035 · 2004-03-24

ApplicantImplant Innovations, Inc.
Decision Date2004-03-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3I PATIENT-SPECIFIC OVERDENTURE BAR 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 2004-03-24 under 510(k) number K034035. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3I PATIENT-SPECIFIC OVERDENTURE BAR?

3I PATIENT-SPECIFIC OVERDENTURE BAR is a medical device that received FDA 510(k) clearance on 2004-03-24. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K034035.

When did 3I PATIENT-SPECIFIC OVERDENTURE BAR receive FDA 510(k) clearance?

3I PATIENT-SPECIFIC OVERDENTURE BAR received FDA 510(k) clearance on 2004-03-24, under 510(k) number K034035.

Who is the listed applicant for 3I PATIENT-SPECIFIC OVERDENTURE BAR?

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 3I PATIENT-SPECIFIC OVERDENTURE BAR?

The FDA product code for 3I PATIENT-SPECIFIC OVERDENTURE BAR is NHA.

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Other records listing Implant Innovations, Inc. as applicant

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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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