Cleared Abbreviated

K132209 - IPS E.MAX CAD ABUTMENT SOLUTIONS

K132209 is an FDA 510(k) clearance for IPS E.MAX CAD ABUTMENT SOLUTIONS, manufactured by Ivoclar Vivadent, AG. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 107-day FDA review.

K132209 · Ivoclar Vivadent, AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
107d
Days
Class 2
Risk

K132209 is an FDA 510(k) clearance for the IPS E.MAX CAD ABUTMENT SOLUTIONS. 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 (Amherst, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 107 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

FDA 510(k) Submission Details - K132209

510(k) Number K132209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2013
Decision Date October 31, 2013
Days to Decision 107 days
Submission Type Abbreviated
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
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Standards-based clearance path.

NHA Device Classification - Class 2, Special Controls

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 653
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K132209.
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
K132844 · Straumann USA, LLC · Jan 2014
ET PROSTHETIC SYSTEM
K130662 · Osstem Implant Co., Ltd. · Jan 2014
MULTI ANGLED ABUTMENT SYSTEM
K132067 · Hiossen, Inc. · Dec 2013
CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS
K122295 · Core 3D Protech, S.L. · Oct 2013
SFI-BAR
K131526 · Cendres & Metaux SA · Sep 2013
CREODENT SOLIDEX CUSTOM ABUTMENT
K113738 · Creodent Prosthetics, Ltd. · Sep 2013