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FDA 510(k)

SMARTBUILDER SYSTEM

K-Number: K120951 · 2012-10-03

ApplicantOsstem Implant Co., Ltd.
Decision Date2012-10-03
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMARTBUILDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2012-10-03 under 510(k) number K120951. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTBUILDER SYSTEM?

SMARTBUILDER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-03. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K120951.

When did SMARTBUILDER SYSTEM receive FDA 510(k) clearance?

SMARTBUILDER SYSTEM received FDA 510(k) clearance on 2012-10-03, under 510(k) number K120951.

Who is the listed applicant for SMARTBUILDER SYSTEM?

The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTBUILDER SYSTEM?

The FDA product code for SMARTBUILDER SYSTEM is JEY.

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Related Devices (Code: JEY)

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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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