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FDA 510(k)

OLYMPUS DENTAL IMPLANT SYSTEM

K-Number: K071070 · 2007-10-23

ApplicantKeystone Dental, Inc.
Decision Date2007-10-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OLYMPUS DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Dental, Inc.. It received FDA 510(k) clearance on 2007-10-23 under 510(k) number K071070. 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 OLYMPUS DENTAL IMPLANT SYSTEM?

OLYMPUS DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-23. The listed applicant is Keystone Dental, Inc.. The 510(k) number is K071070.

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

OLYMPUS DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2007-10-23, under 510(k) number K071070.

Who is the listed applicant for OLYMPUS DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for OLYMPUS DENTAL IMPLANT SYSTEM?

The FDA product code for OLYMPUS DENTAL IMPLANT SYSTEM is DZE.

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Other records listing Keystone Dental, 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.

K240966Prima Plus Conical Implant SystemK223814Genesis ACTIVE Implant SystemK221381KDG AbutmentsK201334Keystone Dental XL Dental Implant SystemK090397XPI ANGLED ABUTMENTSK071599EASYGUIDE

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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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