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FDA 510(k)

ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM

K-Number: K915375 · 1992-06-03

ApplicantOdontit Systeme
Decision Date1992-06-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Odontit Systeme. It received FDA 510(k) clearance on 1992-06-03 under 510(k) number K915375. 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 ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM?

ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-03. The listed applicant is Odontit Systeme. The 510(k) number is K915375.

When did ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM receive FDA 510(k) clearance?

ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM received FDA 510(k) clearance on 1992-06-03, under 510(k) number K915375.

Who is the listed applicant for ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM?

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

What is the FDA product code for ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM?

The FDA product code for ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM 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

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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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