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FDA 510(k)

SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM

K-Number: K941554 · 1994-07-22

ApplicantLifecore Biomedical, Inc.
Decision Date1994-07-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS 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 1994-07-22 under 510(k) number K941554. 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 SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM?

SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-22. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K941554.

When did SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM receive FDA 510(k) clearance?

SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM received FDA 510(k) clearance on 1994-07-22, under 510(k) number K941554.

Who is the listed applicant for SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS 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 SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM?

The FDA product code for SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM 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

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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