Cleared Traditional

Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) (K202100) - FDA 510(k) Clearance

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

K202100 · Neocis, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
82d
Days
Class 2
Risk

K202100 is an FDA 510(k) clearance for the Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS). 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 19, 2020 after a review of 82 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 K202100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2020
Decision Date October 19, 2020
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
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 K202100.
Neocis Guidance System (NGS) with Intraoral Fiducial Array
K211129 · Neocis, Inc. · Jul 2021
Neocis Guidance System (NGS) with Patient Splints (EPS)
K203401 · Neocis, Inc. · Dec 2020
Neocis Guidance System (NGS) with Yomi Plan v2.0
K202264 · Neocis, Inc. · Dec 2020
Neocis Guidance System (NGS) with Patient Splints
K200805 · Neocis, Inc. · Jul 2020
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