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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 the device name listed in this FDA 510(k) record. The listed applicant is Implanter, LLC. It received FDA 510(k) clearance on 2018-12-03 under 510(k) 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. The listed applicant is Implanter, LLC. The 510(k) number is K173083.

When did IMPLANTER DENTAL PLANNING SOFTWARE receive FDA 510(k) clearance?

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

Who is the listed applicant for IMPLANTER DENTAL PLANNING SOFTWARE?

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

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

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.

NCT07515937Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case SeriesRECRUITING

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.

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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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