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FDA 510(k)

NEOSS PROACTIVE TAPERED IMPLANT

K-Number: K113376 · 2012-09-05

ApplicantNeoss, Ltd.
Decision Date2012-09-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEOSS PROACTIVE TAPERED IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Neoss, Ltd.. It received FDA 510(k) clearance on 2012-09-05 under 510(k) number K113376. 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 NEOSS PROACTIVE TAPERED IMPLANT?

NEOSS PROACTIVE TAPERED IMPLANT is a medical device that received FDA 510(k) clearance on 2012-09-05. The listed applicant is Neoss, Ltd.. The 510(k) number is K113376.

When did NEOSS PROACTIVE TAPERED IMPLANT receive FDA 510(k) clearance?

NEOSS PROACTIVE TAPERED IMPLANT received FDA 510(k) clearance on 2012-09-05, under 510(k) number K113376.

Who is the listed applicant for NEOSS PROACTIVE TAPERED IMPLANT?

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

What is the FDA product code for NEOSS PROACTIVE TAPERED IMPLANT?

The FDA product code for NEOSS PROACTIVE TAPERED IMPLANT is DZE.

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Other records listing Neoss, 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.

K211396Neoss Individual ProstheticsK090452NEOSS IMPLANT SYSTEM 03.25K081851NEOSS ACCESS ABUTMENTSK083561NEOSS PROACTIVE IMPLANTK071838NEOSS VARIOUS TITANIUM ABUTMENTSK043195NEO IMPLANT 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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