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FDA 510(k)

SMARTBUILDER SYSTEM (SB1)

K-Number: K130840 · 2013-09-18

ApplicantOsstem Implant Co., Ltd.
Decision Date2013-09-18
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMARTBUILDER SYSTEM (SB1) 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 2013-09-18 under 510(k) number K130840. 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 (SB1)?

SMARTBUILDER SYSTEM (SB1) is a medical device that received FDA 510(k) clearance on 2013-09-18. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K130840.

When did SMARTBUILDER SYSTEM (SB1) receive FDA 510(k) clearance?

SMARTBUILDER SYSTEM (SB1) received FDA 510(k) clearance on 2013-09-18, under 510(k) number K130840.

Who is the listed applicant for SMARTBUILDER SYSTEM (SB1)?

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 (SB1)?

The FDA product code for SMARTBUILDER SYSTEM (SB1) is JEY.

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Related Devices (Code: JEY)

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.

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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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