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FDA 510(k)

SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM

K-Number: K083141 · 2008-11-07

ApplicantSimpact, LLC
Decision Date2008-11-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Simpact, LLC. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K083141. 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 SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM?

SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Simpact, LLC. The 510(k) number is K083141.

When did SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2008-11-07, under 510(k) number K083141.

Who is the listed applicant for SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM?

The FDA product code for SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM is NHA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Simpact, LLC 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.

K081226SIMPACT IMPLANT SYSTEM

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.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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.

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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