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FDA 510(k)

IMMEDIATE STABILIZING IMPLANT (ISI)

K-Number: K033392 · 2003-12-10

ApplicantO Co., Inc.
Decision Date2003-12-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMMEDIATE STABILIZING IMPLANT (ISI) is the device name listed in this FDA 510(k) record. The listed applicant is O Co., Inc.. It received FDA 510(k) clearance on 2003-12-10 under 510(k) number K033392. 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 IMMEDIATE STABILIZING IMPLANT (ISI)?

IMMEDIATE STABILIZING IMPLANT (ISI) is a medical device that received FDA 510(k) clearance on 2003-12-10. The listed applicant is O Co., Inc.. The 510(k) number is K033392.

When did IMMEDIATE STABILIZING IMPLANT (ISI) receive FDA 510(k) clearance?

IMMEDIATE STABILIZING IMPLANT (ISI) received FDA 510(k) clearance on 2003-12-10, under 510(k) number K033392.

Who is the listed applicant for IMMEDIATE STABILIZING IMPLANT (ISI)?

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

What is the FDA product code for IMMEDIATE STABILIZING IMPLANT (ISI)?

The FDA product code for IMMEDIATE STABILIZING IMPLANT (ISI) is DZE.

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Other records listing O Co., 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.

K023336OCO DENTAL IMPLANT (5.0MM DIAMETER)K021460OCO DENTAL IMPLANTK011524IMMEDIATE STABILIZING DEVICE (ISD)K010142OCO DENTAL IMPLANTK973926O BUTMENT HS IMPLANTK961665O BUTMENT ET IMPLANT

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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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