Cleared Traditional

K925700 - ZEST ANCHOR ADVANCED GENERATION (FDA 510(k) Clearance)

Class I Dental device.

K925700 · Zest Anchors, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
511d
Days
Class 1
Risk

K925700 is an FDA 510(k) clearance for the ZEST ANCHOR ADVANCED GENERATION. Classified as Attachment, Precision, All (product code EGG), Class I - General Controls.

Submitted by Zest Anchors, Inc. (Escondido, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3165 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Zest Anchors, Inc. devices

Submission Details

510(k) Number K925700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date April 07, 1994
Days to Decision 511 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
384d slower than avg
Panel avg: 127d · This submission: 511d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGG Attachment, Precision, All
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3165
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.