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FDA 510(k)

SIMPLANT 2011

K-Number: K110300 · 2011-07-01

ApplicantMaterialise Dental NV
Decision Date2011-07-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMPLANT 2011 is the device name listed in this FDA 510(k) record. The listed applicant is Materialise Dental NV. It received FDA 510(k) clearance on 2011-07-01 under 510(k) number K110300. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLANT 2011?

SIMPLANT 2011 is a medical device that received FDA 510(k) clearance on 2011-07-01. The listed applicant is Materialise Dental NV. The 510(k) number is K110300.

When did SIMPLANT 2011 receive FDA 510(k) clearance?

SIMPLANT 2011 received FDA 510(k) clearance on 2011-07-01, under 510(k) number K110300.

Who is the listed applicant for SIMPLANT 2011?

The FDA 510(k) record lists Materialise Dental NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLANT 2011?

The FDA product code for SIMPLANT 2011 is LLZ.

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Other records listing Materialise Dental NV 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.

K120733SIMPLANT GOK113739SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEMK112679SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEMK081402SIMPLANT ORTHO ; VISTADENT 3D

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, 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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