Cleared Traditional

K882063 - MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER (FDA 510(k) Clearance)

Class I Dental device.

K882063 · Zest Anchors, Inc. · Dental device
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Jun 1988
Decision
28d
Days
Class 1
Risk

K882063 is an FDA 510(k) clearance for the MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER. Classified as Attachment, Precision, All (product code EGG), Class I - General Controls.

Submitted by Zest Anchors, Inc. (San Diego, US). The FDA issued a Cleared decision on June 13, 1988 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zest Anchors, Inc. devices

Submission Details

510(k) Number K882063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1988
Decision Date June 13, 1988
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 127d · This submission: 28d
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.