Cleared Traditional

K200348 - Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) (FDA 510(k) Clearance)

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

K200348 · Neocis, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
86d
Days
Class 2
Risk

K200348 is an FDA 510(k) clearance for the Neocis Guidance System (NGS) with Fiducial Array Splint (FAS). 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 May 8, 2020 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neocis, Inc. devices

Submission Details

510(k) Number K200348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2020
Decision Date May 08, 2020
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
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 22
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