Cleared Traditional

K934668 - ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)

K934668 is an FDA 510(k) clearance for ZEST IMPLANT ANCHOR ADVANCED GENERATION..., manufactured by Zest Anchors, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K934668 · Zest Anchors, Inc. · Dental device
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Jun 1994
Decision
266d
Days
Class 2
Risk

K934668 is an FDA 510(k) clearance for the ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zest Anchors, Inc. (Escondido, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 266 days - an extended review cycle.

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

FDA 510(k) Submission Details - K934668

510(k) Number K934668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date June 22, 1994
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · This submission: 266d
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 1047
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K934668.
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K925483 · Nobelpharma USA, Inc. · May 1994
TAPERED ABUTMENT AND RELATED COMPONENTS
K933969 · Implant Innovations, Inc. · Apr 1994