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FDA 510(k)

LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS

K-Number: K002037 · 2001-05-16

ApplicantLifecore Biomedical, Inc.
Decision Date2001-05-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS 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 2001-05-16 under 510(k) number K002037. 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 LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS?

LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K002037.

When did LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS receive FDA 510(k) clearance?

LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS received FDA 510(k) clearance on 2001-05-16, under 510(k) number K002037.

Who is the listed applicant for LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS?

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 LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS?

The FDA product code for LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS is DZE.

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Other records listing Lifecore Biomedical, 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.

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

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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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