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FDA 510(k)

SURGICAL DRILLS

K-Number: K891615 · 1989-04-17

ApplicantImplant Innovations International, Inc.
Decision Date1989-04-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRILLS is the device name listed in this FDA 510(k) record. The listed applicant is Implant Innovations International, Inc.. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K891615. 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 SURGICAL DRILLS?

SURGICAL DRILLS is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is Implant Innovations International, Inc.. The 510(k) number is K891615.

When did SURGICAL DRILLS receive FDA 510(k) clearance?

SURGICAL DRILLS received FDA 510(k) clearance on 1989-04-17, under 510(k) number K891615.

Who is the listed applicant for SURGICAL DRILLS?

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

What is the FDA product code for SURGICAL DRILLS?

The FDA product code for SURGICAL DRILLS is DZE.

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Other records listing Implant Innovations International, 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.

K9355443I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATIONK932123IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEMK911655IMPLARETTEK905303ABUTMENT GLOK911701G-FLOSS & G-FLOSS IIK891613OVERDENTURE ATTACHMENT

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Related Devices (Code: DZE)

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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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