Cleared Traditional

K210947 - Navident (FDA 510(k) Clearance)

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

K210947 · Claronav, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Jun 2022
Decision
454d
Days
Class 2
Risk

K210947 is an FDA 510(k) clearance for the Navident. Classified as Dental Stereotaxic Instrument (product code PLV), Class II - Special Controls.

Submitted by Claronav, Inc. (Toronto, CA). The FDA issued a Cleared decision on June 27, 2022 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Claronav, Inc. devices

Submission Details

510(k) Number K210947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2021
Decision Date June 27, 2022
Days to Decision 454 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
327d slower than avg
Panel avg: 127d · This submission: 454d
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
Devices cleared under the same product code (PLV) and FDA review panel - the closest regulatory comparables to K210947.
Yomi S Robotic System
K252376 · Neocis, Inc. · Oct 2025
Yomi Robotic System
K251835 · Neocis, Inc. · Oct 2025
Navident
K233563 · Claronav, Inc. · Jul 2024
Yomi Robotic System
K231018 · Neocis, Inc. · Aug 2023
Yomi Robotic System with YomiPlan Go
K211466 · Neocis, Inc. · Jun 2022
INLIANT Surgical Navigation System
K213392 · Navigate Surgical Technologies, Inc. · Feb 2022