Cleared Traditional

ImmersiveView Surgical Plan (IVSP®) (K181813) - FDA 510(k) Clearance

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

K181813 · Immersivetouch · Dental device
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Jun 2020
Decision
704d
Days
Class 2
Risk

K181813 is an FDA 510(k) clearance for the ImmersiveView Surgical Plan (IVSP®). Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Immersivetouch (Westmont, US). The FDA issued a Cleared decision on June 9, 2020 after a review of 704 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 Immersivetouch devices

Submission Details

510(k) Number K181813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2018
Decision Date June 09, 2020
Days to Decision 704 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
577d slower than avg
Panel avg: 127d · This submission: 704d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZJ Driver, Wire, And Bone Drill, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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 - DZJ Driver, Wire, And Bone Drill, Manual

All 19
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K181813.
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K181241 · KLS-Martin L.P. · Sep 2018