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FDA 510(k)

3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.

K-Number: K962014 · 1996-10-18

ApplicantImplant Innovations, Inc.
Decision Date1996-10-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. 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 1996-10-18 under 510(k) number K962014. 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 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.?

3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K962014.

When did 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. receive FDA 510(k) clearance?

3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. received FDA 510(k) clearance on 1996-10-18, under 510(k) number K962014.

Who is the listed applicant for 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.?

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 SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.?

The FDA product code for 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. is DZE.

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Other records listing Implant Innovations, Inc. as applicant

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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.

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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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