Cleared Traditional

K061410 - SCREW-VENT IMPLANT SYSTEM, SV

Also marketed or referenced as:
TAPERED SCREW -VENT IMPLANT SYSTEM, TSV ADVENT IMPLANT SYSTEM,AV ZIMMER ONE-PIECE IMPLANT

K061410 is an FDA 510(k) clearance for SCREW-VENT IMPLANT SYSTEM, manufactured by Zimmer Dental, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K061410 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
109d
Days
Class 2
Risk

K061410 is an FDA 510(k) clearance for the SCREW-VENT IMPLANT SYSTEM, SV. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zimmer Dental, Inc. (San Diego, US). The FDA issued a Cleared decision on September 8, 2006 after a review of 109 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

FDA 510(k) Submission Details - K061410

510(k) Number K061410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2006
Decision Date September 08, 2006
Days to Decision 109 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
18d faster than avg
Panel avg: 127d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 1175
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K061410.
SS SYSTEM
K062051 · Osstem Implant Co., Ltd. · Nov 2006
P.0004 IMPLANTS
K062129 · Institut Straumann AG · Oct 2006
SUPER ORTHODONTIC SCREW
K062156 · Osstem Implant Co., Ltd. · Oct 2006
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
K061717 · Zimmer Dental, Inc. · Sep 2006
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
K062281 · Zimmer Dental, Inc. · Sep 2006
STRAUMANN NARROW NECK IMPLANTS
K060958 · Straumann USA · Aug 2006