Cleared Traditional

K801524 - ZEST PLANT

K801524 is an FDA 510(k) clearance for ZEST PLANT, 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 20-day FDA review.

K801524 · Zest Anchors, Inc. · Dental device
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Jul 1980
Decision
20d
Days
Class 2
Risk

K801524 is an FDA 510(k) clearance for the ZEST PLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zest Anchors, Inc. (Walker, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 20 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K801524

510(k) Number K801524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1980
Decision Date July 21, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 128d · This submission: 20d
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 1530
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K801524.
INTRAOSSEOUS DENTAL IMPLANT
K813227 · Pacific Implant, Inc. · Dec 1981
HYDROXI-FLEX IMPLANT
K812321 · Impladent · Oct 1981
R & S SERIES IMPLANTS
K811923 · Suncoast Dental Corp. · Jul 1981
BIOLITE CARBON COATED DENTAL IMPLANT
K791491 · Carbomedics, Inc. · Sep 1979
PYROLITE CARBON ENDOSSEOUS DENTAL IMPL
K791237 · Carbomedics, Inc. · Aug 1979
MONOJECT ENDOSSEOUS DENTAL IMPLANT
K781060 · Sherwood Medical Industries · Aug 1978
K801524 · ZEST PLANT
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