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FDA 510(k)

LORENZ SURGICAL THREADED DENTAL IMPLANT

K-Number: K941619 · 1994-09-29

ApplicantBiomet, Inc.
Decision Date1994-09-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LORENZ SURGICAL THREADED DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1994-09-29 under 510(k) number K941619. 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 LORENZ SURGICAL THREADED DENTAL IMPLANT?

LORENZ SURGICAL THREADED DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1994-09-29. The listed applicant is Biomet, Inc.. The 510(k) number is K941619.

When did LORENZ SURGICAL THREADED DENTAL IMPLANT receive FDA 510(k) clearance?

LORENZ SURGICAL THREADED DENTAL IMPLANT received FDA 510(k) clearance on 1994-09-29, under 510(k) number K941619.

Who is the listed applicant for LORENZ SURGICAL THREADED DENTAL IMPLANT?

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

What is the FDA product code for LORENZ SURGICAL THREADED DENTAL IMPLANT?

The FDA product code for LORENZ SURGICAL THREADED DENTAL IMPLANT is DZE.

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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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