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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 128d · 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 1529
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K934668.
PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO
K926101 · Phoenix Dental, Inc. · Jun 1994
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K924589 · Implant Support Systems, Inc. · Jun 1994
PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN
K926102 · Phoenix Dental, Inc. · Jun 1994
IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM
K932123 · Implant Innovations International, Inc. · May 1994
HAND INSTRUMENT CALCULUS REMOVAL
K925312 · Implant Support Systems, Inc. · May 1994
SPIRAL LOCK DENTAL IMPLANT SYSTEM
K925796 · Robert A James · May 1994
K934668 · ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)
Download PDF FDA Summary Zest Anchors, Inc.