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FDA 510(k)

RESTORE HA DENTAL IMPLANT SYSTEM

K-Number: K954865 · 1996-01-11

ApplicantLifecore Biomedical, Inc.
Decision Date1996-01-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESTORE HA DENTAL 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 1996-01-11 under 510(k) number K954865. 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 RESTORE HA DENTAL IMPLANT SYSTEM?

RESTORE HA DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-11. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K954865.

When did RESTORE HA DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

RESTORE HA DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1996-01-11, under 510(k) number K954865.

Who is the listed applicant for RESTORE HA DENTAL 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 RESTORE HA DENTAL IMPLANT SYSTEM?

The FDA product code for RESTORE HA DENTAL IMPLANT SYSTEM is DZE.

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Other records listing Lifecore Biomedical, 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.

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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