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FDA 510(k)

Osteon Precision Milled Suprastructure

K-Number: K233083 · 2024-03-09

ApplicantImplant Solutions Pty Ltd (Aka Osteon Medical)
Decision Date2024-03-09
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Osteon Precision Milled Suprastructure is the device name listed in this FDA 510(k) record. The listed applicant is Implant Solutions Pty Ltd (Aka Osteon Medical). It received FDA 510(k) clearance on 2024-03-09 under 510(k) number K233083. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Osteon Precision Milled Suprastructure?

Osteon Precision Milled Suprastructure is a medical device that received FDA 510(k) clearance on 2024-03-09. The listed applicant is Implant Solutions Pty Ltd (Aka Osteon Medical). The 510(k) number is K233083.

When did Osteon Precision Milled Suprastructure receive FDA 510(k) clearance?

Osteon Precision Milled Suprastructure received FDA 510(k) clearance on 2024-03-09, under 510(k) number K233083.

Who is the listed applicant for Osteon Precision Milled Suprastructure?

The FDA 510(k) record lists Implant Solutions Pty Ltd (Aka Osteon Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteon Precision Milled Suprastructure?

The FDA product code for Osteon Precision Milled Suprastructure is NHA.

Other records listing Implant Solutions Pty Ltd (Aka Osteon Medical) 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.

K221019Osteon Precision Milled Suprastructure

Related Devices (Code: NHA)

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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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