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FDA 510(k)

SMARTbase Abutment System

K-Number: K223535 · 2023-06-20

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2023-06-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMARTbase Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K223535. 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 SMARTbase Abutment System?

SMARTbase Abutment System is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K223535.

When did SMARTbase Abutment System receive FDA 510(k) clearance?

SMARTbase Abutment System received FDA 510(k) clearance on 2023-06-20, under 510(k) number K223535.

Who is the listed applicant for SMARTbase Abutment System?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTbase Abutment System?

The FDA product code for SMARTbase Abutment System is NHA.

Other records listing Implant Direct Sybron Manufacturing, LLC as applicant

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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

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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