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FDA 510(k)

DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.

K-Number: K891612 · 1989-06-12

ApplicantImplant Innovations International, Inc.
Decision Date1989-06-12
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. 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 1989-06-12 under 510(k) number K891612. The device is classified under product code EFD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.?

DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Implant Innovations International, Inc.. The 510(k) number is K891612.

When did DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. receive FDA 510(k) clearance?

DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. received FDA 510(k) clearance on 1989-06-12, under 510(k) number K891612.

Who is the listed applicant for DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.?

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 DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.?

The FDA product code for DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. is EFD.

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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: EFD)

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

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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