FDA 510(k)

IMPLARETTE

K-Number: K911655 · 1991-10-21

ApplicantImplant Innovations International, Inc.

Decision Date1991-10-21

Product CodeEKJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

IMPLARETTE 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 1991-10-21 under 510(k) number K911655. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLARETTE?

IMPLARETTE is a medical device that received FDA 510(k) clearance on 1991-10-21. The listed applicant is Implant Innovations International, Inc.. The 510(k) number is K911655.

When did IMPLARETTE receive FDA 510(k) clearance?

IMPLARETTE received FDA 510(k) clearance on 1991-10-21, under 510(k) number K911655.

Who is the listed applicant for IMPLARETTE?

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 IMPLARETTE?

The FDA product code for IMPLARETTE is EKJ.

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Other records listing Implant Innovations International, Inc. as applicant

K9355443I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION K932123IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM K905303ABUTMENT GLO K911701G-FLOSS & G-FLOSS II K891613OVERDENTURE ATTACHMENT K891612DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.

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Related Devices (Code: EKJ)

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, 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.