Cleared Traditional

K111421 - SIRONA DENTAL CAD/CAM SYSTEM

K111421 is the FDA 510(k) clearance for SIRONA DENTAL CAD/CAM SYSTEM by Sirona Dental Systems GmbH. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K111421 · Sirona Dental Systems GmbH · Dental device
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Feb 2012
Decision
273d
Days
Class 2
Risk

K111421 is an FDA 510(k) clearance for the SIRONA DENTAL CAD/CAM SYSTEM. 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 Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on February 17, 2012 after a review of 273 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K111421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2011
Decision Date February 17, 2012
Days to Decision 273 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
146d slower than avg
Panel avg: 127d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 477
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K111421.
ZFX DENTAL CAD SYSTEM
K121709 · Zimmer Dental, Inc. · Oct 2012
IPS E.MAX PRESS - ABUTMENT SOLUTIONS
K120053 · Ivoclar Vivadent, AG · Oct 2012
MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM
K121688 · Prismatik Dentalcraft, Inc. · Oct 2012
NNC GOLD ABUTMENT FOR BRIDGES
K113606 · Straumann USA · Jan 2012
ZIMMER CONTOUR PROVISIONAL COPING
K113092 · Zimmer Dental, Inc. · Jan 2012
NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT
K113410 · Straumann USA · Jan 2012