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FDA 510(k)

SQ IS SYSTEM

K-Number: K090825 · 2009-07-16

ApplicantNeobiotech Co., Ltd.
Decision Date2009-07-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SQ IS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2009-07-16 under 510(k) number K090825. 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 SQ IS SYSTEM?

SQ IS SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-16. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K090825.

When did SQ IS SYSTEM receive FDA 510(k) clearance?

SQ IS SYSTEM received FDA 510(k) clearance on 2009-07-16, under 510(k) number K090825.

Who is the listed applicant for SQ IS SYSTEM?

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

What is the FDA product code for SQ IS SYSTEM?

The FDA product code for SQ IS SYSTEM is DZE.

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Other records listing Neobiotech Co., Ltd. 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.

K232528Protective CapK232049IS-III active Short ImplantK210903IS Multi Unit Abutment SystemK190849IS-III active System_S-narrow TypeK181137IT-III active SystemK181138IS-III active 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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