Cleared Traditional

K121709 - ZFX DENTAL CAD SYSTEM

K121709 is the FDA 510(k) clearance for ZFX DENTAL CAD SYSTEM by Zimmer Dental, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K121709 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
130d
Days
Class 2
Risk

K121709 is an FDA 510(k) clearance for the ZFX DENTAL CAD 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 Zimmer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 19, 2012 after a review of 130 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 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 Zimmer Dental, Inc. devices

Submission Details

510(k) Number K121709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2012
Decision Date October 19, 2012
Days to Decision 130 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
3d slower than avg
Panel avg: 127d · This submission: 130d
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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K121709.
INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
K121391 · Prismatik Dentalcraft, Inc. · Dec 2012
IMPLANT BAR
K120858 · Prismatik Dentalcraft, Inc. · Dec 2012
ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
K120873 · Zimmer Dental, Inc. · Nov 2012
MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM
K121688 · Prismatik Dentalcraft, Inc. · Oct 2012
SIRONA DENTAL CAD/CAM SYSTEM
K111421 · Sirona Dental Systems GmbH · Feb 2012
NNC GOLD ABUTMENT FOR BRIDGES
K113606 · Straumann USA · Jan 2012