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FDA 510(k)

SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM

K-Number: K113739 · 2012-05-30

ApplicantMaterialise Dental NV
Decision Date2012-05-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM 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 2012-05-30 under 510(k) number K113739. 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 IMMEDIATE SMILE DENTAL CARE SYSTEM?

SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-30. The listed applicant is Materialise Dental NV. The 510(k) number is K113739.

When did SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM receive FDA 510(k) clearance?

SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM received FDA 510(k) clearance on 2012-05-30, under 510(k) number K113739.

Who is the listed applicant for SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM?

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 IMMEDIATE SMILE DENTAL CARE SYSTEM?

The FDA product code for SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM 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 GOK112679SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEMK110300SIMPLANT 2011K081402SIMPLANT 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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