Cleared Traditional

K143505 - Zimmer Patient-Specific Abutment, Internal Hex, Titanium

K143505 is an FDA 510(k) clearance for Zimmer Patient-Specific Abutment, manufactured by Zimmer Dental, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K143505 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
197d
Days
Class 2
Risk

K143505 is an FDA 510(k) clearance for the Zimmer Patient-Specific Abutment, Internal Hex, Titanium. 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 June 25, 2015 after a review of 197 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 Zimmer Dental, Inc. devices

FDA 510(k) Submission Details - K143505

510(k) Number K143505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2014
Decision Date June 25, 2015
Days to Decision 197 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
70d slower than avg
Panel avg: 127d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 649
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K143505.
LOCATOR RTx
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K150367 · Jjgc Industria E Comercio DE Materiais Dentarios S · Jul 2015
Biodenta Customized Abutment-Hybrid
K150296 · Biodenta Swiss AG · Jul 2015
SternSnap Angled Attachment
K150250 · Sterngold Dental, LLC · Jun 2015
CreoDent Solidex Customized Abutment
K150012 · Creodent Prosthetics, Ltd. · Jun 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
K143528 · Zimmer Dental, Inc. · May 2015