Cleared Traditional

Neocis Planning Software Application (NPSA) for 3rd Party PCs (K191363) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191363 · Neocis, Inc. · Dental device
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Oct 2019
Decision
133d
Days
Class 2
Risk

K191363 is an FDA 510(k) clearance for the Neocis Planning Software Application (NPSA) for 3rd Party PCs. Classified as Dental Stereotaxic Instrument (product code PLV), Class II - Special Controls.

Submitted by Neocis, Inc. (Miami, US). The FDA issued a Cleared decision on October 2, 2019 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Neocis, Inc. devices

Submission Details

510(k) Number K191363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2019
Decision Date October 02, 2019
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 127d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLV Dental Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
Definition To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PLV Dental Stereotaxic Instrument

All 19
Devices cleared under the same product code (PLV) and FDA review panel - the closest regulatory comparables to K191363.
X-Guide® Surgical Navigation System
K200662 · X-Nav Technologies, LLC · May 2020
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
K200348 · Neocis, Inc. · May 2020
X-Guide Surgical Navigation System
K192579 · X-Nav Technologies, LLC · Feb 2020
Neocis Guidance System (NGS)
K191605 · Neocis, Inc. · Sep 2019
Neocis Guidance System
K182776 · Neocis, Inc. · Dec 2018
Neocis Guidance System (NGS) with Chairside Splint
K173402 · Neocis, Inc. · Feb 2018