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FDA 510(k)

EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM

K-Number: K861502 · 1986-06-26

ApplicantDr. Harold Bergman
Decision Date1986-06-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Harold Bergman. It received FDA 510(k) clearance on 1986-06-26 under 510(k) number K861502. 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 EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM?

EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-26. The listed applicant is Dr. Harold Bergman. The 510(k) number is K861502.

When did EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM receive FDA 510(k) clearance?

EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM received FDA 510(k) clearance on 1986-06-26, under 510(k) number K861502.

Who is the listed applicant for EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM?

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

What is the FDA product code for EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM?

The FDA product code for EOH 8501 OSSEOINTEGRATED IMPLANT 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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