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FDA 510(k)

SM IMPLANT SYSTEMS

K-Number: K061797 · 2006-09-01

ApplicantDio Department Dsi, Inc.
Decision Date2006-09-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SM IMPLANT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Dio Department Dsi, Inc.. It received FDA 510(k) clearance on 2006-09-01 under 510(k) number K061797. 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 SM IMPLANT SYSTEMS?

SM IMPLANT SYSTEMS is a medical device that received FDA 510(k) clearance on 2006-09-01. The listed applicant is Dio Department Dsi, Inc.. The 510(k) number is K061797.

When did SM IMPLANT SYSTEMS receive FDA 510(k) clearance?

SM IMPLANT SYSTEMS received FDA 510(k) clearance on 2006-09-01, under 510(k) number K061797.

Who is the listed applicant for SM IMPLANT SYSTEMS?

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

What is the FDA product code for SM IMPLANT SYSTEMS?

The FDA product code for SM IMPLANT SYSTEMS is DZE.

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Other records listing Dio Department Dsi, 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.

K080129SECURE IMPLANT SYSTEM (2.5/3.0MM)K073070DIO BIOTITE-H IMPLANT SYSTEMK080128SM-EXTRA WIDE (RBM) IMPLANT SYSTEMK070570DIO IMPLANT SYSTEMK080126DIO PROTEM IMPLANT SYSTEMK070569SM INTERNAL./EXTERNAL IMPLANT SYSTEM

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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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