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FDA 510(k)

IMPLANTER DENTAL PLANNING SOFTWARE

K-Number: K173083 · 2018-12-03

ApplicantImplanter, LLC
Decision Date2018-12-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPLANTER DENTAL PLANNING SOFTWARE is a medical device manufactured by Implanter, LLC. It received FDA 510(k) clearance on 2018-12-03 under approval number K173083. 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 IMPLANTER DENTAL PLANNING SOFTWARE?

IMPLANTER DENTAL PLANNING SOFTWARE is a medical device that received FDA 510(k) clearance on 2018-12-03. It is manufactured by Implanter, LLC. The 510(k) number is K173083.

When was IMPLANTER DENTAL PLANNING SOFTWARE approved by the FDA?

IMPLANTER DENTAL PLANNING SOFTWARE received FDA 510(k) clearance on 2018-12-03, under approval number K173083.

What company makes IMPLANTER DENTAL PLANNING SOFTWARE?

IMPLANTER DENTAL PLANNING SOFTWARE is manufactured by Implanter, LLC.

What is the FDA product code for IMPLANTER DENTAL PLANNING SOFTWARE?

The FDA product code for IMPLANTER DENTAL PLANNING SOFTWARE is LLZ.

Related Clinical Trials

NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT04975139 Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks ACTIVE_NOT_RECRUITING NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT05439330 Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Treatment Planning RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Related PubMed Literature

PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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