Cleared Traditional

K033699 - LOCATOR BAR FEMALE

K033699 is the FDA 510(k) clearance for LOCATOR BAR FEMALE by Zest Anchors, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K033699 · Zest Anchors, Inc. · Dental device
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Apr 2004
Decision
149d
Days
Class 2
Risk

K033699 is an FDA 510(k) clearance for the LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MOD.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zest Anchors, Inc. (San Diego, US). The FDA issued a Cleared decision on April 22, 2004 after a review of 149 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 Zest Anchors, Inc. devices

Submission Details

510(k) Number K033699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2003
Decision Date April 22, 2004
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
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 430
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K033699.
STRAUMANN DENTAL IMPLANT SYSTEM
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K030685 · Nobel Biocare AB · Feb 2004
KLS-MARTIN ORTHO ANCHORAGE SYSTEM
K033483 · KLS-Martin L.P. · Jan 2004