Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DZE 2020-12-22

Neodent Implant System - Zirconia Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K201491

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EBF 2020-12-22

Opallis, Opallis Flow

Applicant Dentscare Ltda

K-Number K201707

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ODP 2020-12-22

ChoiceSpine Tiger Shark Cervical Spacer System

Applicant Choice Spine, LLC

K-Number K201643

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PNN 2020-12-22

PlaniMax Orthodontic Software

Applicant Choice Biotech, Inc.

K-Number K201036

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OWB 2020-12-22

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X

Applicant Medphoton GmbH

K-Number K203281

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IRP 2020-12-22

Rapid Reboot

Applicant Rapid Reboot Recovery Products, LLC

K-Number K203552

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NXC 2020-12-22

iSMILE

Applicant 3D Diagnostix, Inc.

K-Number K200908

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OBR 2020-12-22

DenTek Fresh Protect Dental Guard

Applicant Medtech Products, Inc.

K-Number K202974

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DYB 2020-12-22

Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set

Applicant Argon Medical Devices, Inc.

K-Number K201489

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GZJ 2020-12-22

actiTENS

Applicant Sublimed

K-Number K202159

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GXI 2020-12-22

COOLIEF Cooled Radiofrequency Kit Advanced

Applicant Avanos Medical, Inc.

K-Number K203066

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NKB 2020-12-22

Nano FortiFix® System

Applicant Nanovis, LLC

K-Number K203452

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