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FDA 510(k)

RENOVA INTERNAL HEX IMPLANT SYSTEM

K-Number: K032774 · 2003-11-26

ApplicantLifecore Biomedical, Inc.
Decision Date2003-11-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RENOVA INTERNAL HEX IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lifecore Biomedical, Inc.. It received FDA 510(k) clearance on 2003-11-26 under 510(k) number K032774. 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 RENOVA INTERNAL HEX IMPLANT SYSTEM?

RENOVA INTERNAL HEX IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-26. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K032774.

When did RENOVA INTERNAL HEX IMPLANT SYSTEM receive FDA 510(k) clearance?

RENOVA INTERNAL HEX IMPLANT SYSTEM received FDA 510(k) clearance on 2003-11-26, under 510(k) number K032774.

Who is the listed applicant for RENOVA INTERNAL HEX IMPLANT SYSTEM?

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

What is the FDA product code for RENOVA INTERNAL HEX IMPLANT SYSTEM?

The FDA product code for RENOVA INTERNAL HEX IMPLANT SYSTEM is DZE.

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Other records listing Lifecore Biomedical, Inc. as applicant

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K073032PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTSK072241PRIMACONNEX CAD/CAM ABUTMENT SYSTEMK072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSK072572PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTSK062876PRIMACONNEX CERAMIC ABUTMENTSK060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.

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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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.

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