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FDA 510(k)

NT/IT SYSTEM

K-Number: K081078 · 2008-07-15

ApplicantOsstem Implant Co., Ltd.
Decision Date2008-07-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NT/IT 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 2008-07-15 under 510(k) number K081078. 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 NT/IT SYSTEM?

NT/IT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K081078.

When did NT/IT SYSTEM receive FDA 510(k) clearance?

NT/IT SYSTEM received FDA 510(k) clearance on 2008-07-15, under 510(k) number K081078.

Who is the listed applicant for NT/IT 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 NT/IT SYSTEM?

The FDA product code for NT/IT 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

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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