Cleared Abbreviated

K191382 - IPS e.max CAD Abutment Solutions- extra systems (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K191382 · Ivoclar Vivadent, AG · Dental device
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Aug 2019
Decision
95d
Days
Class 2
Risk

K191382 is an FDA 510(k) clearance for the IPS e.max CAD Abutment Solutions- extra systems. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on August 26, 2019 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ivoclar Vivadent, AG devices

Submission Details

510(k) Number K191382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2019
Decision Date August 26, 2019
Days to Decision 95 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 701
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