Cleared Traditional

K133339 - ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT

Also marketed or referenced as:
ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED

K133339 is the FDA 510(k) clearance for ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT by Zimmer Dental, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K133339 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
125d
Days
Class 2
Risk

K133339 is an FDA 510(k) clearance for the ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zimmer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 4, 2014 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 K133339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2013
Decision Date March 04, 2014
Days to Decision 125 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
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K133339.
BioHorizons Tapered Internal Implants
K143022 · BioHorizons Implant Systems, Inc. · Jan 2015
ZIMMER 3.1MM DENTAL IMPLANT
K142082 · Zimmer Dental, Inc. · Oct 2014
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · Nobel Biocare AB · May 2014
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013
INCLUSIVE TAPERED IMPLANT SYSTEM
K121406 · Prismatik Dentalcraft, Inc. · Feb 2013
TS IMPLANT SYSTEM
K121585 · Osstem Implant Co., Ltd. · Jan 2013